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

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 - PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041737

Enrollment

100

Registered

2020-09-09

Start date

2020-09-23

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

Uncovered stent Partially covered stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pancreatic cancer patients with jaundice scheduled for neoadjuvant chemo-/chemoradiotherapy: (1) pathological diagnosis of pancreatic ductal adenocarcinoma/adenosquamous carcinoma; (2) clinical diagnosis of resectable/borderline resectable pancreatic cancer according to the 7th edition of the General Rules for the Study of Pancreatic Cancer by the Japan Pancreas Society, which is almost equal to National Comprehensive Cancer Network (NCCN) Guideline Version 1.2020; (3) scheduled for neoadjuvant chemotherapy/chemoradiotherapy; (4) confirmed distal biliary obstruction (defined as stricture at the common bile duct located downstream of the confluence of the cystic duct according to the Classification of Biliary Tract Cancers established by the Japanese Society of Hepato-Biliary-Pancreatic Surgery: 3rd English edition) requiring endoscopic biliary drainage (or a history of endoscopic/percutaneous transhepatic biliary drainage using a plastic stent/tube), which leads to abnormal serum total bilirubin or liver function test results (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, or alkaline phosphatase values not within normal reference ranges at each institution) with or without bile duct dilatation; (5) being 20 or more years of age and (6) willingness to provide informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Biliary event rate until surgery after biliary stenting with a metal stent	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactMasaki Kuwatani

Hokkaido University Hospital Gastroenterology and Hepatology

mkuwatan@med.hokudai.ac.jp011-716-1161

Outcome results

None listed

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