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

NCT01079416 | Completed

• 2 other identifiers: 01-11-047-12K24DK002650
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Esophageal Capsule Endoscopy, Screening

Outcome Measures

Primary Outcomes (1)

• The accuracy of capsule endoscopy for detecting esophageal varices

  June 2006-February 2008

Secondary Outcomes (1)

• Time to perform and interpret capsule endoscopy study

  June 2006-February 2008

Study Arms (2)

Capsule endoscopy

Study device

Device: Capsule endoscopy, Esophagogastroduodenoscopy

Esophagogastroduodenoscopy

Gold standard

Device: Capsule endoscopy, Esophagogastroduodenoscopy

Interventions

Capsule endoscopy, Esophagogastroduodenoscopy DEVICE

Capsule endoscopy; Esophagogastroduodenoscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhotic patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCLA

Los Angeles, California, 11301, United States

Location

Related Publications (2)

• 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.

  PMID: 12016427 BACKGROUND

• 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.

  PMID: 15825071 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Endoscopy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: June 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)