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CompletedNCT01079416Updated Feb 1, 2013

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

An observational study in Esophageal Varices, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-02-01.

Sponsored by University of California, Los Angeles · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Esophageal Varices

Keywords

  • Esophageal Capsule Endoscopy, Screening
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In context

Esophageal and Gastric Varices

169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.

This study's enrollment of 65 is below the median of 130 across 51 observational studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)

Groups and cohorts

  • Capsule endoscopy

    Study device

    Device: Capsule endoscopy, Esophagogastroduodenoscopy

  • Esophagogastroduodenoscopy

    Gold standard

    Device: Capsule endoscopy, Esophagogastroduodenoscopy

Interventions

  • DeviceCapsule endoscopy, Esophagogastroduodenoscopy
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What researchers measure

Primary outcomes

  1. The accuracy of capsule endoscopy for detecting esophageal varices

    Time frame: June 2006-February 2008

Secondary outcomes

  1. Time to perform and interpret capsule endoscopy study

    Time frame: June 2006-February 2008

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Study locations

1 site
  • UCLA
    Los Angeles, California 11301, United States
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References and documents

Publications

  • 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. PubMed 12016427 ↗
  • 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. PubMed 15825071 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01079416
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Disaya Chavalitdhamrong (MD, University of California, Los Angeles) — Principal investigator
First posted
Mar 3, 2010
Start date
Jun 2006
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Feb 1, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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