Clinical trial NCT01079416: Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices
Official title: Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Varices
Keywords: Esophageal Capsule Endoscopy, Screening
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-03-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic patients

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.


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.

Primary outcomes:
measure: The accuracy of capsule endoscopy for detecting esophageal varices
timeFrame: June 2006-February 2008
Secondary outcomes:
measure: Time to perform and interpret capsule endoscopy study
timeFrame: June 2006-February 2008
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
citation: 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.
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. doi: 10.1053/j.gastro.2005.01.047.