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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01079416
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 65
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	Phase
Esophageal Varices	Device: Capsule endoscopy, Esophagogastroduodenoscopy

Study Design

• 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: Jun 1, 2006
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Capsule endoscopy Study device	Device: Capsule endoscopy, Esophagogastroduodenoscopy
Esophagogastroduodenoscopy Gold standard	Device: Capsule endoscopy, Esophagogastroduodenoscopy

Outcome Measures

Primary Outcome Measures

1. The accuracy of capsule endoscopy for detecting esophageal varices [June 2006-February 2008]

Secondary Outcome Measures

1. Time to perform and interpret capsule endoscopy study [June 2006-February 2008]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Jensen DM. Endoscopic screening for varices in cirrhosis: findings, implications, and outcomes. Gastroenterology. 2002 May;122(6):1620-30. Review.
• 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.

• Responsible Party: Disaya Chavalitdhamrong, MD, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01079416
• Other Study ID Numbers: 01-11-047-12; K24DK002650
• First Posted: Mar 3, 2010
• Last Update Posted: Feb 1, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Disaya Chavalitdhamrong, MD, University of California, Los Angeles: Esophageal Capsule Endoscopy, Screening
• Additional relevant MeSH terms: Esophageal and Gastric Varices; Varicose Veins

Study Results

No Results Posted as of Feb 1, 2013