Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent

Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent - Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041704

Enrollment

Registered

2020-09-07

Start date

2020-10-01

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

New therapy: Endoscopic Biliary Drainage by 6mm diameter fully covered self-expandable metallic stent. Observation period: 30days after surgery from the date of stent deployment or the date of the de

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age at the date of registration is between 20 and 79 years. 2) Pancreatic cancer has been diagnosed by imaging or cytology/histology. 3) Resectable or Borderline resectable pancreatic cancer has been determined by contrast-enhanced CT or contrast-enhanced MRI, with neoadjuvant chemotherapy planned. 4) The patient with distal bile duct stenosis by pancreatic cancer needs biliary drainage*. T-Bil>1.5mg/dL, AST>100U/L or ALT>100U/L. 5) No endoscopic transpapilary biliary drainage with plastic stent, Endoscopic nasobiliary drainage, or FCSEMS was performed. *Int patients with a history of percutaneous biliary drainage, the patient was eligible if 5) was met. 6) Major organ functions are preserved. 7) Performance status is kept at 0 and 1. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) The patient has acute cholangitis. 2) Duodenal stenosis is suspected on specific symptoms or imaging studies. 3) The physician determines that the patient's enrollment in the study is inappropriate.

Design outcomes

Primary

Measure	Time frame
Stent-related complications (pancreatitis, non-occlusion cholangitis, cholecystitis, bleeding, perforation)	—

Secondary

Measure	Time frame
Non biliary obstruction rates of per resectable and borderline pancreatic cancer.	—

Countries

Japan

Contacts

Public ContactShota Harai

National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology Division

shotaharai02@gmail.com03-3542-2511

Outcome results

None listed

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