5,557

Endoscopic Management of Common Bile Duct Stones

Alberto Tringali

Alberto Tringali, Endoscopy Unit, Niguarda Hospital, Milano, Italy

Conflict-of-interest statement: The author(s) declare(s) that there is no conflict of interest regarding the publication of this paper.

Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Correspondence to: Alberto Tringali, Endoscopy Unit, Niguarda Hospital, Milano, Italy.
Email: albertotringali@ospedaleniguarda.it
Telephone: +39-0264442770
Fax: +39-0264442901

Received: June 18, 2016
Revised: July 18, 2016
Accepted: July 22, 2016
Published online: December 21, 2016

ABSTRACT

Gallstone disease is one of the most common reason for hospital admission. CBD stones are classified in primary and secondary stone on the basis of the site of origin. Clinical presentation varies from asymptomatic to life threatening conditions such as acute biliary pancreatitis and cholangitis. Patients are categorized in low, intermediate and high risk of choledocholithiasis using clinical, biochemical and imaging factors. Patients with low risk of choledocholithiasis should receive cholecystectomy without further evaluation while it has been recognized the importance of sequential use of EUS-ERCPin patients with intermediate risk of choledocholithiasis to triage patients in need for treatment. Patients with high risk of choledocholithiasis should receive ERCP before performing cholecystectomy although randomized clinical trial showed no benefit for preoperative ERCP over operative cholangiography and common duct exploration. Patients should be received an informed consent and antiplatelet and anticoagulation treatment should discontinued for the appropriate drug-specific interval in according to the recent guideline. Routine administration to all patients undergoing to ERCP is considered unnecessary unless cholangitis or immunosoppression is present or biliary drainage is predicted to be incomplete. All patients undergoing to ERCP should be administered prophylactic drugs such as rectal indomethacin or diclofenac because of consistently reduced risk of post ERCP pancreatitis according to several meta-analysis and ESGE guideline. Endoscopic treatment is based on selective incannulation of the CBD and performing adequate endoscopic sphincterotomy. In case of failed biliary access several reasonable options could be chosen. CBD stone can be removed with either a basket or a balloon catheter in 85-90% of cases and the choice of the better device depends on common bile duct and stone size. Approximately 10-15% of biliary stone are difficult to extract and several technique, such as EPBD, PBSD and ML can be used. Alternative modality for the fragmentation of refractory CBD stone are intraductal lithotripsy (eg. Laser or Electrohydraulic lithotripsy) and ESWL. Mirizzi syndrome is usually treated by surgery although although there have been case reports of endoscopic removal. Intrahepatic stones are treated by dormia basket on guidewire after balloon dilation if stricture is present, or cholangioscopy with intraductal lithotripsy, per-oral cholangioscopic lithotripsy (POCSL) or percutaneous transhepatic cholangioscopy lithotripsy (PTCSL) and surgical resection (Hepatectomy). POCSL and PTCSL are hindered by high rates of stone recurrence. Biliary stenting as definitive treatment of difficult bile duct stone should be reserved for patients with short life expectancy. A review of case series suggest that BS is a safe and effective treatment for common bile duct stone in the pregnant patient but may be associated with higher risk of post ERCP pancreatitis than in the general population.

Key words: Bile duct stone; Gallstone; Choledocholithiasis; Acute biliary pancreatitis; Cholangitis

© 2016 The Author(s). Published by ACT Publishing Group Ltd.

Tringali A. Endoscopic Management of Common Bile Duct Stones. Journal of Gastroenterology and Hepatology Research 2016; 5(6): 2212-2227 Available from: URL: http: //www.ghrnet.org/index.php/joghr/article/view/1933

INTRODUCTION

Gallstone disease is one of the most common reasons for hospital admission[1-3]. Women are two or three times more common than men. About 10-15% adult population develop gallstone, 1-4% will develop symptoms each year[4]. More than 95% of biliary tract disease are related to gallstone[5]. The prevalence of common bile duct stone in patients with symptomatic gallstone varies but probably is about 10-20%[6-7]. Risk factors for gallstone disease are divided in no modifiable and modifiable risk factors as shown in table 1. In detail previous studies have shown that the genetic background accounts for 25% of the total disease risk[8]. Linkage and case-control studies of candidate genes and recent genome-wide studies have identified multiple lithogenic genes, in particular the hepatocanalicular cholesterol transporter ABCG5/G8 and the bilirubin conjugating enzyme UGT1A1, as major genetic determinants of gallstones in humans[8].

Table 1 Risk Factors of gallstone disease.
No modifiable risk factorsModifiable risk factors
Female genderObesity
AsianDiet high calories and low fiber
Family history of gallstoneProlonged fasting
PregnancyRapid weight loss > 1.5 Kg per week
Hypertriglyceridemia/ low HDLDrugs (clofibrate, ceftriaxone, oral contracepotive
Metabolic syndrome 
Cirrhosis/Crohn's disease with severe ileal involvement/resection 
Genetics including genes responsible for biliary transport over hepatic canaliculi and for lipid metabolism 
Polymorphism in gene encoding cholesterol trasnportes ABCG5-G 
Variants of UGT1A1  

TYPES OF CBD STONESF

Common bile dust stones are classified as primary and secondary on the basis of the site of origin.

Primary

Develop de novo in the primary or intrahepatic bile duct. These stone are often brownish-yellow in color, with a soft consistency and consist of calcium bilirubinate mixed with variable amounts of cholesterol and calcium salts. They are more common in Asian population than in the West. While the etiology remains conjectural, bacterial infections and biliary stasis are considered the two most important causative factors. Gastrointestinal tract microorganisms such as Escherichia coli, Proteus, Bacteroides and Clostridium have been isolated from the bile of patients with primary bile duct stones[9].

Secondary

Originate in the gallbladder and then migrate into the common bile duct. It is unclear why gallstones migrate into the common duct in some patients. In one study the size of the cystic duct has been reported as the single most important determinant[10]. Furthermore the presence of multiple small (< 5 mm) stones in the gallbladder posing a 4 fold higher risk of migration into common bile duct as opposed to larger and/or single stone[11]. Factors and mechanism in gallstone formation are reported in table 2.

Table 2 Factors and mechanism in gallstone formation[12,13]
Impaired gallbladder functions (emptying, absorption, secretion)
Supersaturated bile (Age, sex, genetics, obesity, drugs, diet, liver disease)
Cholesterol nucleating factors (mucus, glycoprotein, Infection)
Absorption/entero-hepatic circulation of bile acids (Deoxycholate, bowel transit time, faecal flora, Ileal resection, cholestyramine)

CLINICAL PRESENTATION

Asymptomatic biliary stone

A considerable proportion of patients with common or intrahepatic duct stone are asymptomatic and may found incidentally during investigation for unrelated abdominal conditions.

Symptomatic biliary stones

May cause colicky pain, obstructive jaundice, acute biliary pancreatitis and cholangitis.

Obstructive jaundice: continuous obstruction from stone impaction in the distal CBD at level may manifest as progressive jaundice while when the stone impact and disimpact at the level of papilla or distal part of the CBD may present as fluctuating jaundice. Pain: might be due to an increased pressure into biliary tree

Cholangitis: results from bacterial infection in the setting of biliary obstruction with different range of severity from a self-limited to a potentially life-threatening disease require urgent management. The pathogenesis involves several factors including elevate pressure into bile duct caused by obstruction, increased bacterial growth and bacterial or toxin traslocation into vascular or lymphatic system which may lead to sepsis[14].

Acute biliary pancreatitis: may result from gallstone migration which cause bile-pancreatic duct obstructionwhich increases pancreatic duct pressure, bile reflux, trypsin activation and pancreatic auto-digestion[15].

NATURAL HISTORY

Data regarding natural history of choledocholithiasis are limited. Few studies indicate that 21-34% of CBD stones will spontaneously migrate[16-17], and thus pose a moderate risk of pancreatitis (25-36%)[16,17] or cholangitis in case of obstructed bile duct[18].

DIAGNOSIS

The diagnosis of CBD stone is suspected if patients present with symptoms of abdominal pain, jaundice, and fever other than elevated liver enzymes, alkaline phosphatase or gamma-glutamyl transferase and serum bilirubin. Diagnosis is confirmed with imaging studies showing bile duct dilation and /or presence of common bile duct stones. The diagnostic accuracy with sensitivity and specificity of different diagnostic techniques are summarized in table 3. The normal bile duct diameter is 3 to 6 mm[19-20]. Biliary dilation greater than 8 mm in a patient with an intact gallbladder is usually indicative of biliary obstruction[21].

Table 3 Performance of different diagnostic modalities.
Diagnostic technique Sensitivity Specificity Limit/benefit

US CBD stone/

Dilated CBD/

cholangitis

30%/
42%/
11%

100% /

96% /

99%

 
Helical CT scan
65-88%[25-28]
73-97% Costs /radiation

MRCP
85-92%[29-30]
33-71% small stone (< 6mm)[31-32]
93-97% Performance affects by stone size

EUS (Figure 2)
89-94%[33-34] 94-95% Performance does not affect by stone size[35-37]
Laparoscopic US
71-100%[38] 96-100% 4-10 minutes

No single variable accurately predicts choledocholithiasis and many authors have shown that the probability of a CBD stone is higher in the presence of multiple abnormal prognostic signs[22-24]. There is no single scoring system accepted but using of clinical, biochemical and imaging factors patients can be categorized in low (< 10%), intermediate (10-50%) and high (> 50%) probability to have choledocholithiasis as summarized in table 4.

The higher morbidity of ERCP compared with EUS together with greater diagnostic accuracy of EUS compared with other diagnostic modality has ledto many investigators to agree, in patients with intermediate risk of choledocholithiasis, on the use of sequential EUS and ERCP to triage patients in need of treatment[38-41].

Given the relatively low prevalence (5-10%) of choledocholithiasis in patients with symptomatic cholelithiasis, a normal bile duct on US has a 95%-96% negative predictive value.

Table 4 Predictors of choledocholithiasis.
Predictors of choledocholithiasis[22,23,42,43,44]
Very strong
CBD stone on transabdominal US
Clinical ascending cholangitis
Bilirubin > 4 mg/dL
Strong
Dilated CBD on US (>6 mm with gallbladder in situ)
Bilirubin level 1.8- 4 mg/dL
Moderate
Abnormal liver biochemical test other than bilirubin
Age older than 55 y
Clinical gallstone pancreatitis
Assigning a likelihood of choledocholithiasis based on clinical predictors[22,23,42-46]
Presence of any very strong predictor: High
Presence of both strong predictors: High
No predictors present: Low
All other patients: Intermediate

ALGORITHM OF DIAGNOSIS OF THE CBD STONE

A suggested management algorithm for patients with symptomatic cholelithiasis according to likelihood of CBD stones based on clinical predictors is shown in figure 1.

Figure 1 Probability of choledocholitias according to predictor factors.

Low risk of choledocholithias

Patients with low risk of choledocholithias should undergo cholecystectomy without further evaluation because the cost and risks of additional preoperative imaging test are not justified by the low probability of CBD stone[45,46].

Intermediate risk of choledocholithiasis

Patients with intermediate risk of choledocholithiasis benefit of additional evaluation to rule out the presence of CBD stone[47-48]. The failure to identify CBD stone is burdened by the risk of symptoms recurrence, cholangitis and acute biliary pancreatitis[13,14]. The diagnosis can be performed using magnetic resonance cholangiography, endoscopic ultrasound, intraoperative cholangiography (IOC) laparoscopic US to allow a stone removal at surgery or with postoperative ERCP depending on costs, local expertise.

High risk of choledocholithiasis

Patients with high probability of CBD stone should receive ERCP before surgery, but in the era of laparoscopic randomized clinical trial showed no benefit for preoperative ERCP over operative cholangiography and common duct exploration[49].

Two RCTs compared 2 stage approach (preoperative ERCP followed by laparoscopic cholecystectomy) with an all surgical approach of laparoscopic IOC and trans-cystic stone removal in this setting[50,51] showing that there are no difference in morbidity, mortality or primary ductal clearance rates (88%) between two groups.

Criticism on the use of predictors factors for estabilishing the presence of choledocholithiasis

A recent prospective study By Anderloni et al[52] have shown that the predictors factors are unreliable for predicting the presence of CBD stones. In particular, it is worth noting that 20% of patients stratified in the low-risk group according to clinical parameters were found to have CBD stones by EUS, thus undergoing ERCP and avoiding the risk of further pancreatic damage.

By contrast, in 50% of patients allocated in the high-risk group based on clinical parameters, CBD stones were not found by EUS, thus avoiding unnecessary ERCP.

Some reports showed a superiority of EUS for small stones and biliary sludge, especially if the bile duct is not dilated[30].

In particular, EUS has emerged as an accurate diagnostic tool, as demonstrated by the results of a recent meta-analysis[53]. Moreover the use of EUS significantly reduces the risk of overall complications of interventional ERCP; by performing EUS first, ERCP may be safely avoided in two-thirds of patients with suspected CBD stones[40].

DIAGNOSIS OF CHOLEDOCHOLITHIASIS AFTER CHOLECYSTECTOMY

CBD stone after cholecystectomy can occur from either migrated gallbladder stone or not detected in the perioperative period or less commonly a stone forming de novo in the CBD.

The diagnosis of choledocholithiasis in patients with previous cholecystectomy are slightly different. Although clinical presentation could be similar alternative diagnosis should be considered such as bile leak, iatrogenic biliary stricture and biliary-type sphincter of Oddi dysfunction.

In fact additional diagnostic possibilities to consider in these patients are bile leak, biliary stricture and biliary-type sphincter of Oddi dysfunction. Patients with normal liver test and ultrasound scan are very unlikely to have choledocholithiasis[54]. The incidence of choledocholithiasis after initial evaluation is 33% to 43%[54,55]. MRCP[54] and EUS[55] have been shown to be highly accurate for detecting choledocholithiasis in this subset of patients and preferable approach, given their attenuated morbidity compared with ERCP.

DIAGNOSIS OF CHOLEDOCHOLITHIAS IN PATIENTS WITH ACUTE BILIARY PANCREATITIS

There are no roles of early ERCP in case of absence of evidence of retained CBD stone in patients with mild acute biliary pancreatitis. In patients with ABP and concomitant cholangitis or biliary obstruction, early ERCP is strongly recommended given the benefit shown in morbidity and mortality[56].

Data are conflicting as to the benefit of early ERCP in patients with predicted severe ABP without acute cholangitis or biliary obstruction[57,58]. It is suggested that patients with ABP, being at intermediate risk of choledocholithiasis, should be proposed for pre-operative EUS, MRCP or IOC to rule out CBD stone.

ENDOSCOPIC TREATMENT

Preparation of patients for ERCP

Informed consent: Patients should received detailed informations on risk and benefit to receiving treatment and if appropriate will need to describe the therapeutic alternatives.

Anticoagulation or antiplatelet therapy: Patients who have to undergo ERCP should be performed no more than 72 hours before a full blood count and prothrombin time or international normalised ratio. Patients on anticoagulation should be discontinued prior to ERCP 5 day before and substitute with subcutaneously heparin. The novel oral anticoagulants (NOACs) include the direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors (eg, rivaroxaban [Xarelto], apixaban [Eliquis], and edoxaban [Savaysa]) should be hold, while patients in antiplatelet treatment (APA) need to discontinued treatment for the appropriate drug-specific interval in according to the recent guideline[59-61]. New class agents of Thienopyridines such as ticagrelor (Brilinta) should be hold 5-7 day before while pasugrel (effient) should be hold 10-14 days before.

A new APA agents that are GPIIb/IIA inhibitors such as tirofiban (Aggrastat), abciximab (ReoPro) and Eptifibatide (Integrilin) according to their shorter duration of action, should be hold respectively in 1-2 seconds, 24 hours and 4 hours[61].

Biliary sphincterotomy can be safely performed on patients takin Aspirin or non-steroidal anti-inflammatory drugs. A low dose of heparin should not be considered a controindication to biliary sphincterotomy[59,60].

Antibiotic prophylaxis: Routine administration to all patients undergoing to ERCP is considered unnecessary unless cholangitis or immunosoppression is present or biliary drainage is predicted to be incomplete[62].

Pancreatitis prophylaxis: All patients undergoing to ERCP should be administered prophylactic drugs such as rectal indomethacin or diclofenac because of consistently reduced risk of post ERCP pancreatitis according to several meta-analysis and ESGE guideline[63-65].

Sedation and monitoring: patients should be sedated and monitored with anesthesiology support.

Endoscopic treatment is based on selective biliary cannulation and performing adequate endoscopic sphincterotomy. In case of failed biliary access several reasonable options could be chosen based on several factors including reasons for failure, presence or absence of cholangitis, medical stability and performance status of the patient, whether cholecystectomy is planned, and available expertise.

Both repeated ERCP by the same endoscopist on different days[66] or referral to a tertiary center with ERCP expertise[67] have been reported to have higher rates (88-96%) of selective cannulation. Percutaneous approach (PTC) have been used to facilitate ERCP via transpapillary guidewire passage (rendez-vous technique), with ERCP performed either at the time of PTC[68] or after few days[69]. Moreover PTC has been used for primary percutaneous biliary drainage after failed ERCP although multiple sessions are required expecially if large and multiple stone are found[70].

More recently EUS-guided biliary puncture have been described after ERCP failure for choledocholithiasis[71], but safety profile of this technique is still underway and at the present is reserved in tertiary center with expertise in ERCP and EUS. Surgical intervention is appropriate after failed ERCP, in patients without surgical contraindication, particulary if cholecystectomy is required. Surgical options include both open and laparoscopic CBD exploration and laparoendoscopic rendezvous procedure, during which a guidewire is passed via cystic duct into the duodenum to allow intraoperative ERCP[72].

If selective biliary access occur, after performing sphincterotomy, a cholangiography can show the presence of a stone (Figure 3) that can be removed with either a balloon catheter (Fogarty) (Figure 4a) or a basket (dormia) (Figure 4b). Although no data directly compare their efficacy for uncomplicated CBD stone; the choice of the better device depends on common bile duct and stone size.

Figure 2 Cholangiography showing choledocholithiasis.

Figure 3 EUS showing choledocholithiasis.

Figure 4 A: Stone extraction by ballon; B: Stone extraction by baskets.

In case of stone size are lower of the diameter of common bile duct I usually prefer baskets because of costs, and also because with baskets the vector forces associated with pulling the basket are aligned through the axis of the stone. While with balloon the stone is located lateral to the pull force vector of the catheter, leading to a lateral component which partially impedes stone extraction.

In case of stone size is greater than diameter of CBD (“difficult stone”) it is better to use mechanical lithotripsy or post-sphincterotomy ballon dilation (PSBD).

There are no data comparing different balloons with regard to ease of use and success rates at stone extraction in either the biliary or pancreatic ducts. There are no data to demonstrate the superiority of one extraction balloons device over the others[73]. Expert ERCPist use a Dormia basket first, with a balloon used where residual stones remain following a pull through with a Dormia basket, for extraction of small stones,or small fragment following lithotripsy.

Extraction Maneuver

Balloon technique: The balloon is inserted above the stone. If there are several stones, the stone are removed one at time, starting always with stone closest to the papilla. Keep the balloon in line with axis of the bile duct during stone extraction. The catheter and stone are retracted to the most downstream portion of the duct; The catheter is held tightly against the endoscope with the third through fifth fingers of the left hand. Endoscope is in the same time torqued clockwise and pushed downward which directs the catheter and stone straight out of the duct.

Basket technique: The closed basket is inserted over the stones. If this is difficult guidewire can be placed above the stones and basket inserted over the guidewire. The basket is opened and the stone snared by opening and closing the basket. Sometimes vigorous shaking of the fully open basket inside the bile duct may help to capture the stone into the basket avoiding opening the basket to displace the stone into the intrahepatic ducts. The basket is withdrawn as far as the papilla without closing it aligning the scope with the axis of the CBD.If the stone are very large they may be broken mechanically by the dormia basket. The technical characteristics and type of extraction balloon and baskets are summarized in table 5-6.

Table 5 Types and characteristics of stone extraction balloon *technology Status evaluation Report review ASGE guideline GIE biliary and pancreatic stone extraction device GIE 2009; 70 (4): 603-609.

Manufacturer

Product Balloon inflated OD (mm) Catheter lenght (cm) Injection site {above,below ballon Catheter
OD (Fr)
Recommended guidewire Price ($)
Triple lumen balloons
Boston scientific

Extractor Rx retrieval

9 12”
12 15”
15 18”

NA

Available above or below

7 taper to 6

0.035

209
  Extractor XL retrieval 8.5, 11.5 and 15 210

Available above or below

7 taper to 5

0.035 159
Conmed Technologies
Duraglide stone removal 8.5, 11.5 and 15 200 Available above or below 7 taper to 5 0.035 176
Cook endoscopy

D.A.S.H Extraction

8.5 12.5” 200 Available above or below 6 0.25 160
Tri/ex Radiopaque 8.5,12,15” 200 Above 7 0.35 160
Fusion Quatro Extraction 8.5 10 12 15” and
12/15/18/20”
200 Available above or below 6.6 0.35 199
Fusion extraction 8.5 12 15” 200 Available above or below 7 0.35 199
Multi/3 extraction 8.5 11 15 150 Available above or below 5 at tip
0.35 147
V/system extraction 8.5 11.5 15 190 Available above or below 5.5*at tip 0.35 186
Double/lumen balloons
Boston Scientific Extractor rretrieval 8.5 11 and 15” 210 Above 5 0.25 145
Conmed Duraglide stone retrieval 11.5 15 200 Above 7 0.35 145
Duraglide Tapered stone retrieval 8.5 11.5 and 15 200 Above 7 taper to 5 0.35 145
Cook endoscopy Escort II extrction 8.5 12 15” 200 Above 6.8 0.35 150
15 200 Above 6.8 0.25/0.35 171
Olympus Bouncer multi/pth occlusion 11 195 Above 5 0.35 177
13 350 Above 7 0.35 177
13 195 Above 7 0.35 177

Table 6 Types and characteristics of stone extraction baskets.
Manufacturer Product Opening
width (mm)
Working lenght (cm) Minimum chnnel size (mm) Price ($) Comment
Olympus

Fusion basket

20

200

4.2

376

Lithotriptor compatible

Web extraction 15,20,25 and 30 200 2.8 194 Compatible with Conquest TTC and Sohendra mechanical lithotriptor
Web II extraction 20 200 3.2 194 Soft wire construction. Not for use with ML
Memory basket 5 Fr soft wire 20 200 2 343 Not for use with ML ,soft multifilament wires
Memory Basket 7 Fr hard wire 20,30 200 2.8 343 Not for use with ML ,hard monofilament
Memory basket 7 Fr soft 15,20,25 200 2.8 343 Compatible with Conquest TTC and Sohendra lithotriptor,multifilament 4 wire baket
Mini basket 5 200 2 290 Not for use with ML
Memory basket eight wire 20,30 200 2 343 Not for use with ML,spiral basket configuration
Olympus Flower Basket 20 195 2.8 237  
Stiff wire 22 195 2.8 228  
Stiff wire 22 195 2.8 228  

Problem with ballon an possible solutions: Avoid to inflate balloon in a duct much smaller than the balloon diameter, given the risk of ductal trauma or perforation[74]. Avoid of over-injection contrast material while inflate balloon into the bile duct because can lead to pain during the procedure and the risk of dislocate stone into intrahepatic duct; Use of excessive force to remove the stone can be associate with trauma to the periampullary region, increasing the risk of bleeding, perforation and pancreatitis.

Problem with the Basket and possible solutions: (1) Basket Impacted: represent a medical emergency and rescue lithotripsy using specialized accessories designed for this occurrence may be required. There are several endoscopic solutions: first need to withdraw the endoscope gradually maintaining firm traction on the basket so that scope and basket are integral allowing to the stone to pass through the sphincterotomy. Second advance the scope so that the tip is against the papilla. Force the basket into the operating channel. The basket will close, as it is withdrawn into the operating channel crushig the stone. Third the basket should be attached to the lithotripter and stone crushed[75-79]; (2) Basket mesh rupture: there are two solution: First try to grasp with a forceps the distal end of the basket to pull out from the papilla. Other option include enlarge the opening with balloon dilation of the papilla e distal part of CBD to allow the extraction of the basket and stone with a forceps[80]. Approximately 85-90% of common bile duct stones can be removed with standard technique after ES or EPBD.

Difficult biliary stone

Approximately 10-15% of biliary stone are difficult to extract. Factors influencing the technical difficulty of endoscopic clearance of CBD have been described and are reported in table 7. Furthermore multiple stones (> 10), barrell-shaped stone, proximal CBD stones, Mirizzi syndrome and the presence of distal stricture or primary sclerosing cholangitis (CSP) are also agreed upon by experts to be difficulty of stone extraction[81-82].

Table 7 Cause of difficult bile duct stone.
CategoryRisk factors
Clinical

Age | 65 years.

Bleeding tendence.

Very poor medical condition.

Anatomic situation

Alterated anatomy *Roux/en/Y, gastric bypass, Roux chioledochoenterostomy.

Periampullary diverticulum

Stone characteristics

Stone size > 15 mm.

Barrel shaped, elongated.

Intrahepatic stones.

Multiple stones >10

Bile duct morphology Angulation of the distal CBD < 135°.Distal CBD stricture&PSC. Concomitant Mirizzi syndrome
Patients with "difficult to extract stone" may require adjunct technique for stone extraction which are discussed elsewhere in this article.

table 8 Mechanical lithotriptors. ASGE guideline technical status evolution report Biliary and pancreatic lithotripsy devices GIE 2007,65,6 750.

EPBD: A recent International consensus guideline[83] stated that in the removal of difficult or large CBD stone EPBD can be used as an alternative to EML and could be used as the initial method when large stone have been identified on ERCP or cross sectional imaging and may not increase the risk of pancreatitis as previous described[84,85].

The two previous meta-analysis did not consider some relevant factors that could explain the reason because EPBD is not a risk factors of PEP:

1. Time of insufflation have been demonstrated as important risk factors of PEP. In fact patients who have a longer time of insufflation (5 minute) had a low risk of PEP compared to patient with shorter time of insulation (less than 1 minute)[86-87].

2. The anterograde balloon dilation has not demonstrated an increased risk of post-ERCP pancreatitis supporting the hypothesis that the dilation per se is not a risk factors of PEP[88].

3. Last but not least the increasing use of rectal NSAID has been shown byseveral meta-analysis to reduce the risk of PEP[64] and should also be considered.

PBSD: EPBD after ES using a large balloon (12 to 20 mm) was first used in 2003 as technique to treat patients with large bile duct stone or stone above a distal CBD stricture[89].

A recent met-analysis included 6 RCTs (835 patients) evaluating large balloon dilation (12 mm) treated by EPBD after ES versus ES alone for removal CBD stone 10 mm or larger showed a similar efficacy with stone clearance at first attempt (OR 1.02; p=0.92), reduction in need for mechanical lithotripsy (OR 0.26; p=0.02), lower risk of complication without differences in rates of post ERCP pancreatitis (OR 0.77, p = 0.39)[90].

Mechanical lithotripsy (ML): since the description by Demling et al[91] in 1982, endoscopic mechanical lithotripsy has been accepted as the most reliable method of crushing difficult bile duct stones. The success rate of ML has been improved in the last year[92-93] from 89% to 94%.

The reported incidence of complications with ML ranges from 6% to 13% in large retrospective series[94-95] being pancreatitis and bleeding most common adverse events. Technical complications, such as basket impaction and wire fracture may occur in 4% of cases[96].

ML use a lithotripter that consist of a metal sheath covering a polyethilene catheter contains the basket. The end of the catheter is attached to a lithotripter handle. The basket should be connected to the handle and tested to ensure that is working priori to inserting it. This technique may be performed with traction to the duodenoscope in place or also removing the scope. At the beginning mechanical lithotripsy was performed with an external-type (“salvage procedure”) lithotriptor. Afterwards through-the- scope ML system have largely replaced external lithotripsy systems, given their ease of use and ability to capture and crush multiple stones in 1 session[97].

(1) ML technique with duodenoscope in place (through te scope)(next geration): the bile duct is cannulated with the catheter. The catheter is advanced above the most distal stone. The basket is opened. When the stone has been snared, the catheter is withdrawn until the basket with the stone touches the metal sheath. The stone is then fragmented by forcing the stone against the metal sheath by closing the basket wires.

(2) ML technique with removal of the duodenoscope: use the Sohendra lithotriptor and is used infrequently. If stone are located more proximally in the bile duct must be captured and brought to the papilla. The stone should be capture correctly by the basket. Withdraw the scope while continue to apply traction to the Dormia. Slide the metal sheath under fluroscopic control into the dormia until it makes contact with the stone. Attach the end of the Dormia basket to the lithotripter handle. Apply steady traction to the handle.

Alternative modality for the fragmentation of refractory CBD stone

Intraductal lithotripsy (IDL): may be performed more commonly used a cholangioscopic guidance to allow an accurate stone targeting avoiding injury to the common bile duct wall.

Shock waves may be generated in a fluid medium by a bipolar probe or by pulsed dye laser using a holmium or neodymium: yttrium-aluminum-garnet (YAG) fiber.

ASGE technology status report on biliary and pancreatic lithotripsy device reviews in detail EHL and LL[97]. EHL generate a charge that travel across the tip of the probe setting at 75/90 V, with 5/6 shocks per second during continuous irrigation of the bile duct. The sparks generates rapid expansion of sorrounding fluid and consequent shock-wave transmits energy to the target stone causing fragmentation[97]. Literature supporting this technique has been published only in case series[98]. Anyway EHL has become popular as an established technique for intraductal lithotripsy with a high rate of technical success for extraction of large, complex common bile duct stones.

Intraductal Laser Lithotripsy use a holmium or neodymium yttrium aluminum garnet YAG fiber to conduct a high-energy laser on a stone target generating an oscillating plasma bubble the laser tunnels into and crush the stone. Setting vary by device and manufacter and dedicated training is mandatory[97]. Cases series describing the efficacy of technique reported a clearance of CBD stone greater than 90% and rate of complications less than 10%. Furthermore prospective studies have shown the superiority of EHL over ESWL for first session stone clearance, need for subsequent treatment sessions, shorter procedure duration[99-102]. Unfortunately this technique require long formal training of the physicians and staff, additional cost for personal protection equipment and for purchase of laser unit greater than 50.000 dollars and for device (each fiber cost about 250 to 1,000 dollar that has limited the spread of the technique.

ESWL was first used for urolithiasis, consists of a generation of shock waves in a water medium that travel through the soft tissue of the body arriving at focus point causing a shearing force that crush the stone. The third generation lithotripters do not require a water and have improved focusing, reducing the risk of tissue damage and patient discomfort. CBD stone fragmentation rates of 71% to 95% have been reported[99,100,103-105], leading to ductal clearance rates of 70 to 90%[99,100,103-108]. Usually takes one to three sessions for effective treatment and ERCP is performed within few days to remove fragment from the bile duct. Complication can occur in 10% to 35% of patients undergoing to ESWL including cholangitis, hemobilia, hematuria and transient arrhythmias[99,100,103-105]. Three randomized controlled trials evaluated ESWL compared with EHL[103] or LL[99,100]. In the latter two, LL was associated with a significantly higher rate of ductal clearance than ESWL (83%-97% vs 57-73%), although no difference in ductal clearance rates was seen in the trial comparing EHL and ESWL (74% vs 79%). All 3 trials favoured intraductal lithotripsy over ESWL regarding the number of treatment of sessions required whereas no differences was observed in complications. In summary ESWL has largely been supplanted by intraductal lithotripsy for removal large and complicated CBD stone, the unique indication for ESWL remains as rescue intervention for impacted basket after fragmentation.

Mirizzi Syndrome is characterized by obstruction of the common bile duct by a gallstone impacted in the cystic duct of gallbladder neck. It is uncommon complication of gallstone disease reported in approximately 0.3% in a large series of cholecystectomies[109-110]. Classically the role of endoscopy was to diagnose and relieve biliary obstruction placing a stent before surgery. In last year case series also describe the successful endoscopic stone removal in Mirizzi, after intraductal lithotripsy or ESWL both pre and postoperatively[111,112]. With the advent of ERCP definition of biliary anatomy has led to the classification of Mirizzi into 2 basic types[113,114]. Type I is limited to external compression of the common bile duct stone and type II which is associated with a fistula between the gallbladder and the common bile duct from inflamed and erosion of the impacted stone. Surgical procedure is different for the two types because in case of type 1 laparoscopic cholecystectomy may be used whereas in type II open cholecystectomy is preferable[115].

Intrahepatic (IH) stone: Has always be considered a challenging endoscopic treatment both for the anatomic site and for the underlying stricture-related to post-operative, primary sclerosing cholangitis and recurrent pyogenic cholangitis[116-118]. Ascending cholangitis is a common complication associated with intrahepatic lithiasis and sometimes chronic complication include secondary biliary cirrhosis and cholangiocarcinoma, Management include attempts to exctract with dormia basket on guidewire, after balloon dilation if stricture is present or cholangioscopy with intraductal lithotripsy, per-oral cholangioscopic lithotripsy (POCSL) (ie. Cholangioscopy perfomed at ERCP) or percutaneous transhepatic cholangioscopy lithotripsy (PTCSL) (ie cholangioscopy performed percutaneously via a transhepatic tract or t-tube tract) and surgical resection (Hepatectomy). Cholangioscopy either intraductal lithotripsy although costly and technical challenging, time consuming, is a useful technique in this setting because IH stone are difficult to extract at ERCP because of associated stricture. In a case series of POCSL the rate of complete stone removal was 64%[119] and common causes of failure were the inability to access the postero-inferior and left infero-lateralsegment because of sharp angulations. PTCSL has been proved to be more effective with higher rates of complete stone clearance (80-85%) and thus is more commonly used[120-122]. However both POCSL and PTCSL are hindered by high rates of stone recurrence (22-50% on long term follow up) with biliary stricture predicting recurrence[120-122]. Hepatectomy has been associated with stone clearance rates greater than 90%[123,124] with fewer recurrences and then should be considered for patients with acceptable performance status ad unilateral stone disease, particularly if biliary strictures and/or lobar atrophy are present[125].

Surgically altered anatomy of the upper gut (BII; Roux en Y reconstructions): Endoscopic extraction of CBD stone in patients with altered anatomy is a challenging problem. ERCP in patients with previous reconstructive surgery has been reviewed[128,129]. Before performing ERCP it is paramount to review the surgical report, ensure that require endoscope and device are available and discuss alternative treatments with the patients. Billroth II: Because of retrograde direction of endoscopic approach, the orientation of the major papilla is rotated 180 degrees compared with a typical anterograde approach. A duodenoscope or therapeutic gastroscope can be used to reach the major papilla through the afferent limb with a cannulation success rates approximately 90%[128,129]. ES is performed both specialty papillotome, more commonly using a needle-knife after placement of biliary stent. EPBD is an option in this patient to allow stone extraction because is technically easier to use and effective as shown in a randomized controlled trial[130]. High rates of success (85-92%) have been reported[128,130,131], however post-sphincterotomy bleeding (reported in as many as 17% of patients[130], and perforations (reported in as many as 5% of patients[132] occur more frequently than patients with native anatomy[130,132,133].

Roux-en Y reconstructions: In patients with Roux en Y gastrjejunostomy or hepaticojejunostomy a duodenoscope lacks the length and maneuverability needed to navigate the roux limb to reach the papilla or hepaticojejunostomy[131]. Therefore pediatric colonscope or standard enteroscopes[134-136] and recently balloon-assisted enteroscopes[137-142] have been used. Biliary cannulation with forward viewing endoscopes can be challenging although most authors have reported a native papilla cannulation rates of 70% to 80% if the papilla can be reached[137]. Patients with Roux en Y gastric bypass are different from Roux en Y gastrojejeuniostomy (RYGJ) and hepaticojejnunostomy (RYHJ) for two reasons related to performance of endoscope. First Roux jejunostomy is commonly a greater distance from the stomach resulting in both longer alimentary (Roux) and biliopancreatic limbs and thus potentially more difficult in reaching the biliary orifice. Data reporting access to the biliary orifice in patents with RYG compared to RYGJ or RYHJ when balloon-assisted enteroscope is used are mixed[137,140]. Second, the intact antroduodenal pathway to the biliary tree, makes transgastric approaches possible in RYGB patients which are not options in RYGJ and RYHJ. There are some options such as the creation of a surgical or radiologic gastrostomy into the excluded stomach and subsequent access and dilation of the gastrostomy tract after following 3 to 4 weeks for tract maturation[143,144]. Alternatively, laparoscopic assisted ERCP involves the creation of laparoscopic gastrostomy and intraoperative passage of a duodenoscope via the newly created gastrostomy with success rates of 90% to 100%[145-147]. A gastrostomy tube can be placed to allow an ERCP if repeat intervention is anticipated. Complication rates of as high as 13% have been reported with this technique, including perforation/leak at the gastrostomy site and wound infection[112].

Management of recurrent stone: Recurrent stones have been reported in 3% to 15% of patients in studies with long-term follow up (> 5 years)[148-153]. Several risk factors, other than gallbladder in situ, have been described, generally related to conditions predisposing to bile stasis, including bile duct dilation greater than 15 mm[151,152], and anatomic lesions that may impede bile flow (eg periampullary diverticula[151,154], angulation of the CBD[155], and biliary or papillary stricture[156]. Most of recurrent stones are brown pigment stone[152], whose formation is dependent on bacterial and composition and pathogenesis differ significantly from those of other types of stone[157]. In patients with CBD stone recurrence, biliary stasis and its predisposing factors may be difficult to correct and alternatively strategy should be considered. A annual ERCP surveillance have been reported in a small case series with a reduction in frequency of ascending cholangitis[158]; while the role of UDCA remain very limited because of different pathogenesis respect to cholesterol stones. Anyway recurrent stone can be managed by ERCP with a high rate of success[152,159]. Surgical approach have been reported[160-162] with high rate of in-hospital mortality as much as 5%[163] and a 10% to 28% of adverse event rate, including cholangitis, sump syndrome, bile leak, and wound infection[164-167], as such the role of surgery is limited to patients refractory to nonsurgical management[168].

Figure 5 Algorithm for management of choledocholithiasis.

CONTROVERSIES

Stenting for untreatable common bile duct stones

In cases of incomplete stone extraction or severe acute cholangitis a biliary endoprosthesis should be placed to ensure adequate biliary drainage[3]. Plastic biliary stent appears to be as effective as nasobiliary drainage in the management of ascending cholangitis[169-171]. Plastic biliary stent have been reported increase technical success at subsequent ERCP with stone clearance rates of 60% to 90%[172-174] and reduce the stone size or even absent after a period of stenting[175-177]. However biliary stenting as a definitive therapy for difficult bile duct stones should be avoided because of associated biliary morbidity (mostly cholangitis ranging from 36% to 63%) and mortality (6% to 21% during a median follow up times of 20-39 months) as shown in 4 studies[178-181]. Therefore biliary stenting as definitive treatment of difficult bile duct stone should be reserved for patients with short life expectancy[3,182].

ERCP vs laparoscopic common bile duct exploration for retained CBD stones

The role of ERCP in the treatment of CBD stone in patients with planned cholecystectomy for concomitant gallstone is controversial. Three options in the use of ERCP in the treatment of CBD stone have been described: preoperative, intraoperative and post-operative ERCP. Preoperative ERCP is reserved for patients with high probability of CBD stone[38,39] or in case of positive intraoperative cholangiograhy[183,184] an sometimes post-operative[185,186] in case of unavailable endoscopist, have all been described, without a conclusive superiority with anyone strategy[183]. However each ERCP-associated strategy is associated with some warnings. Preoperative ERCP remains a risk of interval migration of additional gallbladder stones before and during cholecystectomy[187] and misuse of preoperative ERCP exposing patients to the risk of unnecessary ERCP. Intraoperative ERCP is difficult to plan especially in the era of scarce human and financial resources. Post-operative ERCP is usually performed in the case where there are residual stones or migrated during surgery in the bile duct.

If preoperative ERCP is undertaken, laparoscopic cholecystectomy should be performed within 2 weeks because longer delays have been proved to be associated with risk of cholecystitis, gallstone pancreatitis, and high rates of conversion to open cholecystectomy in retrospective series[188-191] and in one RCTS showing a 36% incidence of recurrent biliary events[192]. Several subsequent randomized controlled trials evaluated in a Cochrane meta-analysis involving 663 participants have compared a prophylactic cholecystectomy to a watch and wait approach reporting a higher rates of mortality (RR 1.78, 95% CI 1.15 to 2.75, p = 0.010) and morbidity with recurrent biliary pain (RR 14.56), cholangitis (2.53), need for repeated ERCP (RR 2.36) and cholecystectomy in the watch and wait arm[193]. As such cholecystectomy is recommended for most patients with colelithiasis after ductal clearance given the relatively low morbidity of laparoscopic cholecystectomy. An important and challenging issue is the outcomes associated with laparoscopy cholecystectomy LC plus laparoscopic common bile duct explorations (LCBDE) are comparable with those of LC plus selective endoscopic stone extraction (ESE). In a randomized controlled trial has been shown that are similar regardless of whether ESE is performed preoperatively or postoperatively[50,51,194,195]. A single stage (LC+LCBDE) may be associated with shorter hospital stay[51,194] and cost-effectiveness[48]. However given that LCBDE does not appear to be superior to a dual stage procedure in term of efficacy, morbidity and mortality[195,49] therefore the most important considerations in choosing the treatment approach are local availability and expertise.

CBD stone in Pregnancy: A review of case series suggest that BS is a safe and effective treatment for common bile duct stone in the pregnant patient[196-198] but may be associated with higher risk of post ERCP pancreatitis than in the general population[198]. The foetus should be appropriately shielded and it is important keeps radiation exposure to a minimum limiting fluoroscopy time and minimise the risk of aspiration from gastroesophageal reflux in women in the 2nd and 3rd trimester of pregnancy performing ERCP under general anesthesia with endotracheal intubation and remembering that in late pregnancy supine position can induce hypotension and should be avoided. Same-session EUS immediately prior to scheduled ERCP may eliminate the need for ERCP and its risks in pregnant patients with no evidence of choledocholithiasis on EUS. In patients with confirmed choledocholithiasis, EUS provided additional information regarding the location, number and size of bile duct stones, which enabled the successful clearance of the bile duct without the use of fluoroscopy[199]. The use of non-radiation ERCP has been reported in recent studies by Akcakya et al[200] that reported that in experienced hands ERCP can be performed safely during pregnancy without fluoroscopy confirming the correct cannulation of the bile duct bile aspiration and/or visualization of the bile oozing around the guidewire. Laparoscopic cholecystectomy have been reported to be successfull in pregnant patient[201,202].

CONCLUSIONS

Common bile duct stone (CBDS) represent a challenging clinical condition and most common reason for hospital admission. The diagnosis of CBD stone is based on predictor factors that allow to categorize patients into low-intermediate and high risk and receive the correct treatment. Clinical presentation ranges from asymptomatic to life threatening conditions such as acute biliary pancreatitis and cholangitis. The timing of ERCP respect to cholecystectomy depends on the risk of choledocholithiasis. Endoscopic management of CBD stones is become the golden standard of treatment and in the 90% of cases the method of extraction is based on the ballon or dormia basket. In 5-10% of cases stone are difficult to extract. In such cases endoscopic papillary ballon diltion (EPBD), post-sphincterotomy balloon dilation (PBSD) and mechanical lithotripsy (ML) are used to exctract stone. Alternative methods used in case of refractory BD stone are intraductal lithotripsy and ESWL although intraductal lithotripsy (EHL, LL) are considered more efficacious than ESWL. Mirizzi syndrome, intrahepatic stone and common bile duct stone in patients with altered anatomy are considered conditions that make difficult the stone extraction. CBD stone extractions in pregnant patients are considered safe but with higher risk of pancreatitis and for this reason care should be taken. A single stage (LC+LCBDE) compared with dual stage (ERCP plus LC) may be associated with shorter hospital stay and cost-effectiveness. However given that LCBDE does not appear to be superior to a dual stage procedure in term of efficacy, morbidity and mortality, choosing the most appropriate treatment is based on local availability and expertise. Biliary endoprosthesis could be placed to ensure adequate biliary drainage in cases of incomplete stone extraction or severe acute cholangitis but should be avoided as a definitive therapy because of associated biliary morbidity and mortality and should be reserved for patients with short life expectancy.

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