Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | May 2008 |
| Contact: | Paul J Thuluvath, MD |
| Email: | pjthuluv@jhmi.edu |
| Phone: | 410-614-5389 |
The purpose of this study is to develop a grading system for esophageal varices using
capsule endoscopy in patients with portal hypertension and cirrhosis.
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.
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
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