Enhancing Detection of Small Esophageal Varices by PillCam ESO

Phase 3

Withdrawn

• Conditions: Esophageal Varices
• Interventions: Device: Capsule endoscopy (PillCam ESO) with abdominal binder; Device: Capsule endoscopy (PillCam ESO); Procedure: EGD

• Registration Number: NCT00911131
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients identified with grade I and grade II esophageal varices by conventional endoscopy who are returning for screening or surveillance
• patients who have had endoscopic banding of varices in the past
• patients aged 18 years or older
• patients able to give consent
• patients eligible and willing to undergo upper endoscopy and PillCam ESO capsule endoscopy

Exclusion Criteria

• dysphagia

• Zenker's diverticulum

• pregnancy

• esophageal stricture

• gastric or intestinal obstruction

• multiple abdominal surgeries

• cardiac pacemakers

• implanted electronic medical devices

• cognitive impairment

• also, patients found to have bleeding, requiring banding, or other complications on screening EGD the day of the trial will not proceed to capsule endoscopy

• urine pregnancy test will be conducted prior to participation; this is part of the standard procedure for women of child-bearing age undergoing upper endoscopy in the GI lab

• all patients being evaluated for the current study will be evaluated for the presence or absence of overt portosystemic encephalopathy:

  • Those found to have overt portosystemic encephalopathy will then be graded based on the standard scale of grade 1 through 4 portosystemic encephalopathy. Assessment of whether patients with liver disease and hepatocellular carcinoma possess decisional capacity is essentially the same as for other subjects with the exception that due diligence must be used to address whether there is any evidence of active ongoing overt portosystemic encephalopathy. From the available data and current standards of care, patients with stage 1 overt hepatic encephalopathy are decisional but may have minimal impairment in their cognitive skills particularly in the domains of attention and sleep. Decisional capacity in patients with grades 2-4 overt portosystemic encephalopathy is impaired and will lead to them bring excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Capsule Endoscopy with abdominal binder	Capsule endoscopy (PillCam ESO) with abdominal binder	Before swallowing the capsule endoscope, an inflatable girdle is wrapped around the waist above the umbilicus and held in place by a an abdominal binder. The pressure is increased by 10mmHg for 10 minutes. The PillCam ESO is placed in the mouth and the patient is asked to swallow it with 100cc of water with simethicone in the supine position. Recording is done for 2 minute in this position and then the head is elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient sips 10cc of water and after 15 seconds, they sit upright and sip water again. They can then walk and resume normal activity for 15 minutes.
Capsule Endoscopy	Capsule endoscopy (PillCam ESO)	The capsule endoscope will be swallowed by the participant with 100cc of water and simethicone in the supine position. Recording is done for 2 minute in this position and then the head will be elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient will sip10cc of water and after 15 seconds, they will sit upright and sip water again. They can then walk and resume normal activity for 15 minutes. The videos will be reviewed and graded by a gastroenterologist experienced with capsule endoscopy and will be blinded to the patient's clinical and procedural history as well as the most recent EGD. The varices will be graded using the Given Imaging software that grades varices as no varices (C0), small varices or \< 25% of esophageal circumference (C1), and large varices or \> 25% of esophageal circumference (C2).
Screening esophagoduodenoscopy (EGD)	EGD	EGD will be performed utilizing conscious sedation. During EGD, the endoscopist will capture pictures of the esophageal body, Z-line, lower esophagus and proximal gastric folds. Grading of esophageal varices will be performed by all investigators using the Italian Liver cirrhosis project. Patients who are found to have small grade varices and meet the inclusion and exclusion criteria will be enrolled in the study.

Primary Outcome Measures

Name	Time	Method
Detection rate of esophageal varices using different screening modalities.	30 days

Secondary Outcome Measures

Name	Time	Method
Patient tolerability of each screening modality.	1 day