Enhancing Detection of Small Esophageal Varices by PillCam ESO

Esophageal Varices Clinical Trial

Official title: A New Technique to Enhance Detection of Small Esophageal Varices by PillCam ESO Capsule Endoscopy

Status Withdrawn

Clinical Trial Summary

Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure within smaller esophageal varices which will therefore enhance the ability of capsule endoscopy to detect these varices better.

Therefore, the aims of the investigators' study are as follows:

1. To determine if using an abdominal binder to increase IAP can increase the detection rate of small esophageal varices when using capsule endoscopy.

2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a comparable detection rate of small esophageal varices to conventional endoscopy.

Clinical Trial Description

Esophageal variceal bleeding is a common and life-threatening complication of portal hypertension in patients with cirrhosis of liver. It is associated with a mortality rate of up to 50% in these patients. Prophylactic treatments to prevent variceal bleeding, therefore, assume paramount clinical significance. Currently, primary prophylactic treatments using pharmacologic agents with non-selective beta blockers as well as endoscopic variceal ligation (EVL) are effectively employed in preventing variceal bleeding. The American Association for the Study of Liver Disease (AASLD) guidelines recommend that patients with Child's stage A cirrhosis and portal hypertension with platelet count less than 140,000/mmq or portal vein diameter > 13mm and those patients classified as Child's B and C cirrhosis should undergo screening endoscopy for esophageal varices. Patients with cirrhosis and no esophageal varices detected during screening should undergo endoscopy ever three years. Patients with small esophageal varices are recommended to be screened endoscopically every 1 to 2 years.

Currently, esophagogastroduodenoscopy (EGD) under conscious sedation is the gold standard for variceal screening. However, EGD has certain limitations especially when used in patients with cirrhosis of the liver. Prolonged conscious sedation may have an adverse effect on encephalopathy. EGD also may not be cost effective for screening esophageal varices.

The use of PillCam ESO capsule endoscopy to detect esophageal varices has become an attractive alternative to conventional endoscopy especially in patients unwilling to undergo EGD. Identifying patients with small varices, which have the potential for progression to large varices and bleeding, is an important clinical issue to address. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Varicose Veins

• NCT number: NCT00911131
• Study type: Interventional
• Source: Medical College of Wisconsin
• Status: Withdrawn
• Phase: Phase 3