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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Disaya Chavalitdhamrong, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01079416
First received: March 1, 2010
Last updated: January 31, 2013
Last verified: January 2013

March 1, 2010
January 31, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
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.
 
Completed
65
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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01079416
01-11-047-12, K24DK002650
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP