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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079416
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : February 1, 2013
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Disaya Chavalitdhamrong, University of California, Los Angeles

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.

Condition or disease Intervention/treatment
Esophageal Varices Device: Capsule endoscopy, Esophagogastroduodenoscopy

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
Study Start Date : June 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Capsule endoscopy
Study device
Device: Capsule endoscopy, Esophagogastroduodenoscopy
Gold standard
Device: Capsule endoscopy, Esophagogastroduodenoscopy

Primary Outcome Measures :
  1. The accuracy of capsule endoscopy for detecting esophageal varices [ Time Frame: June 2006-February 2008 ]

Secondary Outcome Measures :
  1. Time to perform and interpret capsule endoscopy study [ Time Frame: June 2006-February 2008 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079416

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United States, California
Los Angeles, California, United States, 11301
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: Disaya Chavalitdhamrong, MD, University of California, Los Angeles Identifier: NCT01079416    
Other Study ID Numbers: 01-11-047-12
K24DK002650 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by Disaya Chavalitdhamrong, University of California, Los Angeles:
Esophageal Capsule Endoscopy, Screening
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases