Esophageal and Gastric Varices
Conditions
Keywords
Esophageal Varices, Gastric Varices, Capsule Endoscopy, Portal Hypertension, Cirrhosis, Gastrointestinal Hemorrhage
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.
Interventions
DEVICEUpper Gastrointestinal Endoscopy
Sponsors
Ethicon, Inc.
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. | Two years |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Two years |
Countries
United States
Outcome results
None listed