Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
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About
The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.
Full 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.
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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
Trial design
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Interventional model
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0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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