Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  Purpose

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 Intervention
Esophageal Varices
 Device: Capsule endoscopy, Esophagogastroduodenoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • The accuracy of capsule endoscopy for detecting esophageal varices [ Time Frame: June 2006-February 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to perform and interpret capsule endoscopy study [ Time Frame: June 2006-February 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Capsule endoscopy
Study device
 Device: Capsule endoscopy, Esophagogastroduodenoscopy
Esophagogastroduodenoscopy
Gold standard
 Device: Capsule endoscopy, Esophagogastroduodenoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cirrhotic patients

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079416

Locations
United States, California
UCLA
Los Angeles, California, United States, 11301
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:

Responsible Party: Disaya Chavalitdhamrong, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01079416     History of Changes
Other Study ID Numbers: 01-11-047-12, K24DK002650
Study First Received: March 1, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Esophageal Capsule Endoscopy, Screening

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal and Gastric Varices
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
 Hypertension, Portal
Liver Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013