Clinical trial NCT00475592: Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
Official title: Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal and Gastric Varices
Keywords: Esophageal Varices
Gastric Varices
Capsule Endoscopy
Portal Hypertension
Cirrhosis
Gastrointestinal Hemorrhage
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2007-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

Detailed description: Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.

The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.

The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.

Eligibility criteria: Inclusion Criteria:

* Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
* Age greater than or equal to 18 years old
* Able to give consent

Exclusion Criteria:

* Current implantable cardioverter-defibrillators or pacemaker in place
* Suspected intestinal obstruction
* Esophageal swallowing disorder
* Esophageal stenosis
* Age less than 18 years old
* Pregnancy
* Known Zenker's diverticulum
* Patients with previous endoscopic or surgical esophageal treatment

Primary outcomes:
measure: The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.
timeFrame: Two years
Secondary outcomes:
measure: Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.
timeFrame: Two years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Paul J Thuluvath, MD
role: PRINCIPAL_INVESTIGATOR
References: