study failed to recruit

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

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.

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