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