Clinical trial NCT00911131: Enhancing Detection of Small Esophageal Varices by PillCam ESO
Official title: A New Technique to Enhance Detection of Small Esophageal Varices by PillCam ESO Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Esophageal Varices
Keywords: Small grade esophageal varices
capsule endoscopy
PillCam ESO
abdominal binder
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2009-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of esophageal varices using different screening modalities.
timeFrame: 30 days
Secondary outcomes:
measure: Patient tolerability of each screening modality.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wisconsin
name: Kia Saeian, MD
role: STUDY_DIRECTOR
affiliation: Medical College of Wisconsin
name: Mukund Venu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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