Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
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|ClinicalTrials.gov Identifier: NCT00475592|
Recruitment Status : Withdrawn (study failed to recruit)
First Posted : May 21, 2007
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal and Gastric Varices||Device: Esophageal Capsule Endoscopy Device: Upper Gastrointestinal Endoscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy|
|Actual Study Start Date :||January 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
|Experimental: Capsule Endoscopy||Device: Esophageal Capsule Endoscopy|
|Active Comparator: Upper Gastrointestinal Endoscopy||Device: Upper Gastrointestinal Endoscopy|
- The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. [ Time Frame: Two years ]
- Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods. [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475592
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Paul J Thuluvath, MD||Johns Hopkins University|