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A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery

A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery - A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032076
Enrollment
200
Registered
2018-04-04
Start date
2018-04-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

conventional therapy:Endoscopic Biliary Drainage by 10 Fr plastic stent. Observation period: postoperative day 120 or death. new therapy:Endoscopic Biliary Drainage by Fully covered self-expandable m

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 20 years old. regardless of sex. 2) Written informed consent 3) resectable or borderline resectable pancreatic cancer 4) adenocarcinoma or adenosquamous carcinoma or obvious pancreatic cancer 5) with distal biliary obstruction 6) need for Biliary Drainage 7) less than 2 weeks from Biliary Drainage

Exclusion criteria

Exclusion criteria: 1) under 2cm from hilar bile duct to stenosis 2) with Gastric outlet obstruction 3) with Serious complications 4) endoscopic approach is difficult 5) except Billroth I reconstruction 6) Benign stenosis 7) Hilar bile duct stenosis 8) more than 2 weeks from Biliary Drainage 9) less than 2 weeks until operation 10) with metastasis 11) Pregnant women

Design outcomes

Primary

MeasureTime frame
Any symptoms from the time of biliary stent placement to the surgery. In other patients, the outcome will be the time to the decision not to undergo surgery.

Countries

Japan

Contacts

Public ContactAkinori Suzuki

Juntendo University Gastroenterology

suzukia@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026