CTRI/2013/04/003584Not yet recruiting未知
EUS-Guided Biliary Drainage in Patients with Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
All India Instittue of Medical Sciences0 sites20 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institutionâ??s definition of â??failedâ?? procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at our institution can be considered as total of two failures.
- •2.Ability to give informed consent
Exclusion Criteria
- •1.Unable to give informed consent
- •2.Life expectancy < 1month
- •3.Pregnant or breastfeeding women
- •4.Acute gastrointestinal bleeding
- •5.Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000
- •6.Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- •7.Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
- •8.Cirrhosis with portal hypertension, varices, and/or ascites
- •9.Liver metastases burden > 30%
Investigators
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