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

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ClinicalTrials.gov Identifier: NCT01079416
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):

March 1, 2010
March 3, 2010
February 1, 2013
June 2006
February 2008   (Final data collection date for primary outcome measure)
The accuracy of capsule endoscopy for detecting esophageal varices [ Time Frame: June 2006-February 2008 ]
Same as current
Complete list of historical versions of study NCT01079416 on ClinicalTrials.gov Archive Site
Time to perform and interpret capsule endoscopy study [ Time Frame: June 2006-February 2008 ]
Same as current
Not Provided
Not Provided
Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices
Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
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.
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Cirrhotic patients
Esophageal Varices
Device: Capsule endoscopy, Esophagogastroduodenoscopy
  • Capsule endoscopy
    Study device
    Intervention: Device: Capsule endoscopy, Esophagogastroduodenoscopy
  • Esophagogastroduodenoscopy
    Gold standard
    Intervention: Device: Capsule endoscopy, Esophagogastroduodenoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
K24DK002650 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Disaya Chavalitdhamrong, University of California, Los Angeles
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
University of California, Los Angeles
January 2013