Randomized controlled trial of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer

Randomized controlled trial of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer - PS versus CSEMS for resectable and borderline resectable pancreatic cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048867

Enrollment

Registered

2022-09-07

Start date

2022-10-06

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

Interventions is to place a 6-mm diameter covered self-expandable metallic stent for malignant distal biliary obstruction Control is to place a 10-Fr plastic stent for malignant distal biliary obstruc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients =or >18 years of age 2) pathological diagnosed invasive ductal carcinomas 3) ECOG performance status 0 or 1 4) diagnosed resectable pancreatic cancer or borderline-resectable pancreatic cancer with portal vein contact 5) schedueled for neoadjvant therapy 6) malignant distal biliary obstruction 7) providing written informed consent

Exclusion criteria

Exclusion criteria: 1) diagnosed bordeline-resectable panvreatic cancer with arterial contact 2) previous biliary drainage with metallic stent 3) under 2cm from hilar bile duct to obstruction 4) with Gastric outlet obstruction 5) after gastric surgery (excluding Billroth-I) 6) history of metal allergy

Design outcomes

Primary

Measure	Time frame
rate of recurrent biliary obstruction	—

Countries

Japan

Contacts

Public ContactMasafumi Watanabe

Kitasato University School of Medicine Department of Gastroenterology

m.wata@kitasato-u.ac.jp+81427788111

Outcome results

None listed

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