Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices

Completed

• Conditions: Esophageal Varices
• Interventions: Device: Capsule endoscopy, Esophagogastroduodenoscopy

• Registration Number: NCT01079416
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal varices and related lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Age at least 18 years and less than 86 years at the time of consent.
• Clinically evident or biopsy proven cirrhosis.
• No previous documented UGI bleeding due to peptic ulcers, varices, portal hypertensive gastropathy, angiomas, or watermelon stomach.
• No previous endoscopic, radiological or surgical treatment for variceal bleeding or ascites.
• Probable life expectancy of at least 24 months without liver transplantation, as judged by the hepatologist and endoscopist-investigators, and have a Model for End-Stage Liver Disease (MELD) score ≤ 29.
• Signed a written informed consent.

Exclusion Criteria

• Prior variceal bleeding- esophageal, gastric, or other site.
• Prior endoscopic (e.g. sclerotherapy, ligation, or combination therapy), radiological (e.g. transjugular intrahepatic portosystemic shunt-TIPS) or surgical (e.g. portocaval or splenorenal shunt) treatment of esophagogastric varices or ascites.
• Patient who was uncooperative or unable to give written consent.
• Severe co-morbid illness, e.g. end stage chronic renal disease (e.g. dialysis dependence, creatinine greater than 2 times normal) or respiratory failure (e.g. ventilator dependent, oxygen dependent, unstable asthma or chronic obstructive pulmonary disease- e.g. 2 or more hospitalizations for exacerbation in 1 year, asthma or obstructive pulmonary disease which required daily bronchodilators and/or oral/inhaled steroids), tense ascites requiring repeated therapeutic paracenteses, severe hepatic encephalopathy, peritonitis, or sepsis.
• Active cancer with less than a 24 month expected survival and/or cancer on active treatment with chemotherapy and/or radiation therapy.
• Esophageal motility disorder, esophageal stricture or esophageal diverticulum, causing dysphagia or requiring dilatation.
• GI obstruction or partial obstruction (by history or imaging), symptomatic GI stricture or pseudo-obstruction which may prevent passage of the capsule.
• Patients with potentially reversible portal hypertension such as alcoholic hepatitis, acute viral hepatitis, untreated autoimmune hepatitis, or chronic hepatitis B or C on viral therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capsule endoscopy	Capsule endoscopy, Esophagogastroduodenoscopy	Study device
Esophagogastroduodenoscopy	Capsule endoscopy, Esophagogastroduodenoscopy	Gold standard

Primary Outcome Measures

Name	Time	Method
The accuracy of capsule endoscopy for detecting esophageal varices	June 2006-February 2008

Secondary Outcome Measures

Name	Time	Method
Time to perform and interpret capsule endoscopy study	June 2006-February 2008

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States