Esophageal and Gastric Varices Clinical Trial
Official title:
Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
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.
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