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

Esophageal and Gastric Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00475592
• Other study ID #: VaricealGrading_EsoCapsule
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2007
• Last updated: July 20, 2017
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices

Intervention

Device:
• Esophageal Capsule Endoscopy

• Upper Gastrointestinal Endoscopy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.		Two years
Secondary	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.		Two years

External Links

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