JPRN-jRCT1032230171
Recruiting
Phase 3
Multicenter Randomized Controlled Trial of Endoscopic Stenting with Duckbill type Anti-Reflux Metal Stent vs Conventional Covered Metal Stent for Malignant Distal Biliary Obstruction after Dysfunction of Previous Covered Metal Stent in Unresectable Pancreatic Cancer - RESTART trial
Sasahira Naoki0 sites154 target enrollmentJune 25, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pancreatic cancer
- Sponsor
- Sasahira Naoki
- Enrollment
- 154
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Unresectable pancreatic cancer
- •2\)Prior history of one endoscopic stenting with covered metal stent
- •3\)Dysfunction of previous covered metal stent
- •4\)Age \>\= 18 years
- •5\)Performance status of 0\-2
- •6\)Expected survival time over 3 months
- •7\)Sufficient organ function
- •1\.Neutrophil count \>\= 1,000 /microL
- •2\.Hemoglobin level \>\= 7\.0 g/dL
- •3\.Platelet count \>\= 50,000 /microL
Exclusion Criteria
- •1\)Concomitant hilar biliary obstruction
- •2\)Patients who require more than one biliary stent
- •3\)Unable to remove the previous covered metal stent
- •4\)Surgically altered anatomy other than Billroth 1 reconstruction
- •5\)Indwelling Pholangitis
- •7\)Cholecystitis requiring gallbladder drainage
- •8\)Liver abscess requiring abscess drainage
- •9\)Liver failure
- •10\)Indwelling gastroduodenal stent covering the duodenal papilla
- •11\)Uncontrolled gastrointestinal obstruction
Outcomes
Primary Outcomes
Not specified
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