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Clinical Trials/CTRI/2013/04/003584
CTRI/2013/04/003584
Not 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 enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
All India Instittue of Medical Sciences
Enrollment
20
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
All India Instittue of Medical Sciences

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%

Outcomes

Primary Outcomes

Not specified

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