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

Esophageal Varices Clinical Trial

Official title:

Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079416
• Other study ID #: 01-11-047-12
• Secondary ID: K24DK002650
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: January 31, 2013
• Start date: June 2006
• Est. completion date: February 2008

Study information

• Verified date: January 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices

Intervention

Device:
• Capsule endoscopy, Esophagogastroduodenoscopy

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jensen DM. Endoscopic screening for varices in cirrhosis: findings, implications, and outcomes. Gastroenterology. 2002 May;122(6):1620-30. Review. — View Citation

Jutabha R, Jensen DM, Martin P, Savides T, Han SH, Gornbein J. Randomized study comparing banding and propranolol to prevent initial variceal hemorrhage in cirrhotics with high-risk esophageal varices. Gastroenterology. 2005 Apr;128(4):870-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of capsule endoscopy for detecting esophageal varices		June 2006-February 2008	Yes
Secondary	Time to perform and interpret capsule endoscopy study		June 2006-February 2008	Yes