Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

Conditions
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Esophageal and Gastric Varices

Intervention / Treatment
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* Device: Esophageal Capsule Endoscopy
* Device: Upper Gastrointestinal Endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsule Endoscopy<br> | Device: Esophageal Capsule Endoscopy<br> <br> |
| Active Comparator: Upper Gastrointestinal Endoscopy<br> | Device: Upper Gastrointestinal Endoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Varices, Gastric Varices, Capsule Endoscopy, Portal Hypertension, Cirrhosis, Gastrointestinal Hemorrhage