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

NCT ID: NCT01079416

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-02-29

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.

Conditions

Esophageal Varices

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Capsule endoscopy

Study device

Capsule endoscopy, Esophagogastroduodenoscopy

Intervention Type: DEVICE

Esophagogastroduodenoscopy

Gold standard

Capsule endoscopy, Esophagogastroduodenoscopy

Intervention Type: DEVICE

Interventions

Capsule endoscopy, Esophagogastroduodenoscopy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Disaya Chavalitdhamrong

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

Jensen DM. Endoscopic screening for varices in cirrhosis: findings, implications, and outcomes. Gastroenterology. 2002 May;122(6):1620-30. doi: 10.1053/gast.2002.33419.

Reference Type: BACKGROUND

PMID: 12016427 (View on PubMed)

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. doi: 10.1053/j.gastro.2005.01.047.

Reference Type: BACKGROUND

PMID: 15825071 (View on PubMed)

Other Identifiers

K24DK002650

Identifier Type: NIH

Identifier Source: secondary_id

View Link

01-11-047-12

Identifier Type: -

Identifier Source: org_study_id