Status:
WITHDRAWN
Enhancing Detection of Small Esophageal Varices by PillCam ESO
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Esophageal Varices
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 thes...
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00911131
Last Update
June 19 2015
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