A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Not Applicable
Recruiting
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-UMIN000041737
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
(1) history of biliary drainage with a metal stent; (2) history of chemotherapy/chemoradiotherapy for pancreatic cancer; (3) biliary obstruction that progresses to the hepatic hilum; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 4; (5) history of gastrointestinal tract reconstruction except for Billroth I reconstruction; (6) the major duodenal papilla unreachable by a duodenal endoscope; (7) current pregnancy or suspected pregnancy; (8) unsuitable for inclusion at the discretion of the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biliary event rate until surgery after biliary stenting with a metal stent
- Secondary Outcome Measures
Name Time Method (1) curative resection rate (2)Time to Recurrent biliary obstruction (3)Chemotherapy accomplishment/delay/discontinuation (4)Other stent-related adverse events (5)Frequency and severity of adverse events after curative surgery