A
Prospective Study Comparing Real Time Video Capsule Endoscopy to Standard
Endoscopy in Patients with Suspected Upper Gastrointestinal Bleeding
Arkady Broder,
Timothy C Johnson, David P Hudesman, Jonathan Mazurek, Frank Chateau, Brett B
Bernstein
Arkady Broder, Timothy C Johnson, David P
Hudesman, Jonathan Mazurek, Frank Chateau, Brett B Bernstein, Division
of Digestive Disease, Beth Israel Medical Center 350 East 17th Street, 17th
Floor, New York, NY, 10003, United States
Jonathan Mazurek, Department of
Medicine, Beth Israel Medical Center350 East 17th Street, 20th Floor, New York,
NY, 10003,United States
Correspondence to: Arkady Broder, MD, Division of Digestive Disease, Beth Israel Medical Center
350 East 17th Street, 17th Floor, New York, NY, 10003,
United
States. abroder@chpnet.org
Telephone:
+1-212-844-1832 Fax: +1-212-420-4373
Received: December 11, 2011 Revised: January 23,
2012
Accepted: January 31, 2012
Published online: February 21, 2012
ABSTRACT
To determine the
diagnostic yield, quality of risk stratification, and patient tolerability of
real time video capsule endoscopy (RT-VCE) as compared to standard upper
endoscopy and official video capsule endoscopy (O-VCE) in patients presenting
with UGIB. A total of 20 patients were evaluated during our trial
period. An official interpretation of the VCE (O-VCE) was performed by an
experienced endoscopist and documented before the end of the day. Overall
cumulative findings and their clinical significance were evaluated using the
RT-VCE and O-VCE interpretations as compared to gold standard EGD. The level of
agreement in individual re-bleeding risk was compared using EGD versus VCE
obtained Rockall scores. A
questionnaire on patient tolerability and satisfaction was administered after
both procedures were completed. Prospective analysis
revealed that EGD and RT-VCE identified both low acuity and high acuity lesion
at statistically similar rates (79% vs. 68%, p=0.157, and 21% vs. 32%, p=0.157
respectively). There was high level of agreement between the post endoscopy
Rockall scores obtained for RT-VCE, O-VCE and EGD (Spearman correlation
coefficient of 0.97 and 0.86 respectively, p<0.0001). Real time
capsule endoscopy was the self reported preferable diagnostic test of choice.
RT-VCE has similar lesion detection rates when compared to both standard EGD
and O-VCE, and may serve as a risk stratification tool in patients who present
with suspected UGIB, and are at high risk for cardiopulmonary complications
from EGD.
© 2012 Thomson
research. All rights reserved.
Key words: Upper gastrointestinal bleeding (UGIB);
Video capsule endoscopy (VCE); Real time video capsule endoscopy (RT-VCE);
Official video capsule endoscopy (O-VCE)
Broder
A, Johnson TC, Hudesman DP, Mazurek J, Chateau F, Bernstein BB. A Prospective Study Comparing Real Time Video Capsule
Endoscopy to Standard Endoscopy in Patients with Suspected Upper
Gastrointestinal Bleeding. Journal of Gastroenterology and Hepatology Research 2012;
1(1): 11-15 Available from: URL: http://www.ghrnet.org/index./joghr/
INTRODUCTION
Upper gastrointestinal hemorrhage accounts for more
than 400 000 hospital admissions per year. The majority of upper
gastrointestinal bleeds (80 to 90%) are classified as non-variceal, with
gastroduodenal peptic ulcer being most common[1].
Mortality associated
with peptic ulcer bleeding remains as high as 5-10%, despite advances in
endoscopic diagnostic and therapeutic options[1]. In the United
States estimated direct medical costs for the in-patient care of peptic ulcer
related bleeding total more than $2 billion annually[2].
In an emergent setting, immediate endoscopic support carries with it
the risk of sedation induced cardiopulmonary complications which account for a
majority of the potential EGD related complications[3] thereby at
times limiting the therapeutic and diagnostic utility of EGD. Additionally,
early endoscopy in low to moderate risk patients is likely to be of little
long-term clinical benefit[4]. This dilemma often leaves clinicians
with a greater need to accurately, safely, and rapidly risk-stratify patients
presenting with upper gastrointestinal bleeding (UGIB). Several risk
stratification tools have been established to help triage patients presenting
with UGIB. The 11 point Rockall score is probably the most widely known
risk-stratification scale and has been validated in numerous health care
settings[5]. Furthermore, the Rockall score has been shown to best
identify patients at low risk for re-bleeding and mortality[6].
BACKGROUND
Video capsule endoscopy (VCE) is a technology that
has been FDA approved for the detection of bleeding in the gastrointestinal
tract. Since it was introduced in 2000 video capsule endoscopy has become a
gold standard for the investigation of patients with obscure gastrointestinal
bleeding[7], as well as other intestinal diseases, including
inflammatory bowel disease and celiac disease. There is little evidence,
however, for the application of VCE technology in the risk stratification of
patients with suspected acute upper gastrointestinal bleeding.
CE has high positive (95%) and negative predictive values (83–100%),
demonstrating the best clinical accuracy in patients in whom ongoing
gastrointestinal bleeding is suspected[8]. Recent clinical
investigations have suggested that even if the culprit lesion is not directly
visualized, CE during an acute bleeding episode may determine the location of
the bleeding with subsequent impact on therapy and clinical outcomes[9,10]. In recent years a real-time viewer
compatible with VCE has become available for the immediate evaluation of
gastrointestinal pathology. After the patient swallows the standard video
capsule, a portable tablet computer allows for live viewing, image backup and
even remote transmission of obtained images.
There is only one other study evaluating this novel technology for its
use in acute UGIB[11]. We aimed to prospectively determine the
diagnostic yield, quality of risk assessment, and patient tolerability of the
real-time video capsule as compared to the gold standard upper endoscopy in
patients presenting with acute upper gastrointestinal hemorrhage.
METHODS
A total of 20 patients that presented to the
emergency department or were admitted to our medical facility with a presumed
diagnosis of UGIB from October 2007 to May 2008 were consecutively enrolled in
the pilot study. Inclusion criteria included all patients who were able to
tolerate an endoscopic procedure, and able to provide consent for the
endoscopic studies. Additionally, patients included were those with presumed
non-emergent UGIB, defined as those who had a history of melena and/or coffee
ground emesis, but did not exhibit signs and symptoms of hemodynamic
instability. Exclusion criteria included the need for urgent endoscopy in those
patients who had evidence of ongoing bleeding, such as persistent hematemesis,
hematochezia, or hemodynamic instability. Patients who were unable to give
informed consent, had a GI tract related procedure within the previous 30 days,
or had known contraindications to capsule endoscopy (such as intestinal
obstruction, implantable electronic devices, and difficulty swallowing) were
also excluded.
The identity of patients and their medical records were kept
confidential and the study protocol was approved by the institutional review
board (IRB) of Beth Israel Medical Center. After completing an IRB approved
informed consent, each subject first underwent real-time video capsule
endoscopy (RT-VCE) using the M2A Pillcam (Given Imaging Ltd, Yoqneam, Israel).
The studies were conducted in the emergency department or the endoscopy suite
within 24 h of presentation. The
RT-VCE is similar to standard capsule endoscopy; a set of electrodes were
placed on the skin of the abdominal wall with real-time viewing made possible
by linking a hard disk worn by the patient to a portable tablet computer at the
patient’s bedside. The size of the
resulting image is 640-480 pixels, allowing for an adequate analysis of the
study[12]. The real-time images were viewed until the M2A Pillcam
reached the second portion of the duodenum. To aid in transit time, patients in
whom the duodenum was not visualized after 30 min were given 10mg IV
metoclopramide. Patients were subsequently taken to the endoscopy suite for a
complete EGD performed by an experienced endoscopist. An official
interpretation of the VCE (O-VCE) was performed by an experienced endoscopist
and documented before the end of the day. The endoscopist who performed the EGD
was blinded to the results of the VCE and vice versa.
Patient data regarding age, gender, procedure indications, baseline hemoglobin
levels, comorbid conditions, need for prokinetics administration, complication
rates, and study results were collected. RT-VCE is a relatively new advance in
capsule endoscopy, and as such there is likely a variable learning curve in
interpreting video imaging. In an attempt to elucidate the precision of
diagnostic interpretation of RT-VCE pathology, we compared endoscopist
observations during real time viewing (RT-VCE) versus the standard video
capsule endoscopy interpretation methodology (O-VCE). Overall cumulative
findings and their clinical significance were evaluated using the RT-VCE and
O-VCE interpretations as compared to gold standard EGD. To allow for
statistical sub analysis and a more accurate comparison of pathology, study
findings were grouped into two major categories, low acuity and high acuity
lesions. Low acuity lesions included findings of gastritis, duodentis,
gastrointestinal polyps, red spots, and gastropathy that would not typically
require emergent endoscopy and/or invasive therapy (Figure 1a and 1b). The second group of findings
included gastro-duodenal ulcers, fresh blood, and arteriovenous malformation,
which typically would require invasive therapies, such as endoscopic hemostasis,
interventional angiography with possible embolization, and surgical
intervention (Figure 2a and 2b).
The previously validated Rockall post-endoscopy scores were obtained for
both VCE and EGD separately, by an operator blinded to either study. The level
of agreement in individual re-bleeding risk was compared using EGD versus VCE
obtained Rockall scores.
A questionnaire on patient tolerability and satisfaction was
administered after both procedures were completed. The questionnaire consisted
of a total of 4 questions. The patients were asked to rank on a scale of 0-9
the level of discomfort experienced during VCE versus EGD, they were also asked
to report the preferred procedure and should a repeat study be necessary their
preference in procedure type.
Statistical
Analysis
Spearman comparison coefficients[13] were measured to
detect the level of correlation between Rockall scores obtained from patients
who underwent RT-VCE versus EGD. In those patients whose Rockall scores did not
correlate 100% of the time (Spearman coefficient=1), we conducted a subanalysis
to determine the number of units the RT-VCE obtained score differed from the
EGD obtained score. Descriptive statistical analyses were performed to evaluate
any related trends in patient demographics and procedure findings. A two tailed
Fisher exact test was performed to calculate p values for the comparison
of findings between VCE findings and gold standard EGD. A p value
<0.05 was considered statistically significant.
RESULTS
A total of 20 patients who met enrollment criteria for
the prospective portion of our pilot study were analyzed (Table 1). The average age was 65, with mostly
males (65%) comprising the study population. The vast majority of the cohort
(85%) presented with a recent history of melena, with the remaining presenting
with coffee ground emesis. The average hemoglobin concentration at the time of
presentation was 7.5 g/dL. A previous history of UGIB was reported in 30% of
the study population. Seventy percent of the patients had a history of
clinically significant cardiac disease and would normally be considered at
moderate-high risk to undergo conscious sedation for the purpose of EGD. All of
the patients were given a PPI pre-endoscopy. After 30 min of study time the
duodenum was not visualized in 35% of the cohort, requiring 10mg IV
metoclopramide to aid in gastric transit. The mean gastric transit time was 25
min. In total the real time capsule reached the duodenum in 85% (17/20) of
subjects, while in 15% (3/20) of subjects the VCE did not reach the duodenum due
to a hiatal hernia, equipment malfunction, and a case of gastroparesis
refractory to metoclopramide. Among the 3 patients in whom the duodenum was not
reached only 1 patient had a non-diagnostic study and was excluded from final
analysis.
After diagnosis of the source of bleeding, the majority (80%; 16/20) of
the study population did not require invasive endoscopic intervention and were
treated with PPI’s alone. The other 4 patients (20%) received invasive
endoscopic therapy. Of the 4 patients who needed endoscopic therapy, 2 patients
had bleeding gastric polyps and were successfully treated with hemostatic
clips. One patient had an actively
bleeding gastric lipoma successfully treated with two hemostatic clips and
bipolar cautery. One patient with an
actively bleeding gastric adenocarcinoma required surgical intervention,
despite two endoscopic attempts at hemostasis.
Overall, clinically significant pathologic findings (total N=40) were
identified at fairly similar rates during both O-VCE and corresponding EGD
examinations (Table 2a). Video capsule endoscopy was relatively better at
identifying pathologic vascular lesions as a cause of UGIB.
The mean
Rockall scores (0-11) for RT-VCE and O-VCE versus gold standard EGD were 3,
2.95, and 2.9 respectively. The level of agreement between the Rockall scores
obtained for O-VCE versus EGD were highly in concurrence, with a Spearman
correlation coefficient of 0.86 (p<0.0001). When compared within one
Rockall unit the RT-VCE findings exhibited an ever higher level of agreement
with EGD pathology, reflected by an almost perfect Spearmen correlation of 0.97
(p<0.0001, Table 2b).
Rockall scores for EGD and
O-VCE were also found to be clinically equivalent, exhibiting perfect agreement
70% of the time and within one Rockall unit 90% of the time.
For further analysis the endoscopic findings were grouped into low
acuity and high acuity lesions.
Both EGD and RT-VCE identified low acuity lesions at a statistically
similar rate (79% vs. 68% respectively, p=0.157). Furthermore, the rate
of identification of fresh blood, gastroduodenal ulcers, and AVMs during RT-VCE
versus EGD were also similar (21% vs. 32% respectively, p=0.157) (Table
3). A comparison of EGD versus O-VCE identified both low acuity and high acuity
lesions at statistically similar rates (Table 3). Notably both RT-VCE and O-VCE
identified all of the lesions which would normally require invasive therapy,
such as gastroduoenal ulcers, fresh blood or AVMs seen during EGD.
The 4 point questionnaire on patient tolerability and satisfaction had a
90% completion rate, with one patient unable to complete. Discomfort levels
were graded from 0-9 with a score of 9 being most severe. Although pain levels
were very low for both procedures (Table 4), slightly more patients reported a
higher level of discomfort during RT-VCE (0.8 [±1.8 SD] vs. 0.4 [±1.8 SD]
respectively). Strikingly a greater proportion of patients preferred RT-VCE
(32% vs. 5% respectively), although the majority (63%) cited no difference in
preference. Similarly more patients cited RT-VCE as the preferable procedure
for potential repeat investigation (42% vs. 10% respectively).
DISCUSSION
Capsule endoscopy remains the preferred modality for
mucosal imaging of the entire small intestine, as well as the recommended diagnostic
tool of choice in the setting of obscure gastrointestinal bleeding[14].
The International Conference for Capsule Endoscopy (ICCE) guidelines for the
evaluation of obscure GI hemorrhage in patients with active, ongoing,
mild-to-moderate, overt UGIB recommended capsule endoscopy as a viable and
early utilized diagnostic option [15]. Furthermore, capsule
endoscopy has clearly been demonstrated to have high positive and negative
predictive values, while providing the best clinical accuracy for patients in
whom ongoing gastrointestinal bleeding is suspected[8, 16].
Clinicians are often
faced with the additional challenge of accurately and safely risk stratifying
patients based on the presumed severity of the gastrointestinal hemorrhage. To
date there remains a small body of literature supporting the feasibility and
accuracy of real-time capsule endoscopy in triaging patients who present to the
emergency department with a history of UGIB[17]. Our study
investigates the diagnostic accuracy and utility of RT-VCE in the setting of
suspected acute UGIB as compared to standard EGD.
This prospective study revealed very similar results for capsule
endoscopy and EGD in the detection of UGIB sources. EGD, when compared to both
RT-VCE and O-VCE, did not show any statistically significant difference in its
ability to diagnose low acuity lesions and high risk lesions, such as fresh
blood, ulcers, and AVMs. Most
notably all lesions requiring invasive endoscopic or surgical therapy were
identified by both RT-VCE and O-VCE.
The Rockall scores
(0-11) obtained during initial presentation to the emergency room for RT-VCE
and O-VCE versus gold standard EGD were almost identical. Patient discomfort
was self reported as very similar and overall minimal during both EGD and
RT-VCE. On the other hand, RT-VCE was overwhelmingly preferred as both a first
line test as well as a repeat investigative tool for the diagnosis of
gastrointestinal bleeding in the appropriate setting. Other techniques have
been investigated to allow for adequate assessment of the upper
gastrointestinal tract in the setting of suspected UGIB, while minimizing the
risk of sedation related cardiopulmonary complications. The performance of
unsedated upper endoscopy using ultrathin videoendoscopes passed both perorally
and transnasally, have been studied as alternatives to standard EGD[18,19,20].
Studies have demonstrated that these techniques preserve diagnostic accuracy,
while potentially mitigating the cardiopulmonary complications associated with
sedation. Nevertheless, the use of ultrathin videoendoscopes may be problematic
as it is associated with gagging, trauma and significant patient discomfort.
Given its low level of discomfort, patient preference, and comparable
performance to standard EGD, it would appear that RT-VCE may prove to be
superior to ultrathin endoscopy for the assessment of the high-risk patient
with suspected UGIB. Further studies can be performed to compare both the
diagnostic accuracy and patient tolerability of RT-VCE to that of ultrathin
endoscopy.
We acknowledge that VCE has some technical limitations. It can not be
used to obtain biopsy specimens or for endoscopic treatment, and it can not at
this time be controlled remotely. As such, the lack of ability to control the
path of the video capsule coupled with its relatively rapid transit time,
prevents it from examining all parts of the stomach and duodenum, thereby
potentially limiting its diagnostic yield. It is conceivable therefore, that certain
anatomical areas of the stomach are visualized more frequently than others.
Additional studies would be needed to determine whether this is indeed the
case.
Furthermore, although
complication rates for VCE are relatively low, capsule retention is a real
concern as was observed in one of our patients. While these findings have
exciting implications for the future role of VCE in the risk stratification of
patients with acute upper gastrointestinal bleeding, our conclusions are
limited by the need for further investigation in a larger and statistically
powered prospective randomized trial would be necessary before firm conclusions
can be reached.
In our patient
population real time capsule endoscopy is the self reported preferable
diagnostic test of choice and appears to be a safe and viable option for the
initial management of acute GI bleeding in non-critically ill patients. In
combination with the Rockall risk assessment score, this technology was
prospectively able to accurately identify those patients at risk for
potentially adverse outcomes. Real-time endoscopy may improve the timing of
necessary treatment, and may help to avoid the unnecessary risk of sedation and
endoscopic examination in high risk patients. The impact of real-time capsule
examination on mortality and risk of re-bleeding certainly warrants further
investigation.
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Peer reviewers: Dr. Seng-Kee Chuah, Division of Hepatoga- stroenterology, Kaohsiung Chang Gung Memorial Hospital, 123, Ta-Pei
Road, Niao-sung Hsiang, Kaohsiung County, 833 Taiwan; Denise Kalmaz, MD,
Assistant Clinical Professor, Department of Gastroenterology, University of
California, San Diego, 9500 Gilman Drive (ECOB/ 2nd Fl/ 2-062H), 0956 La Jolla,
CA 92093-0063, USA.
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