A prospective clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered biliary metal stent

A prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered metal stent for preoperative biliary drainage in resectable/borderline resectable pancreatic cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042200064

Enrollment

Registered

2020-11-16

Start date

2021-01-25

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

Transpapillary Biliary stent implantation with 7 mm diameter covered metal stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)A patient who is planned to undergo first endoscopic biliary stent placement for jaundice or cholangitis. 2)A patient with resectable or borderline resectable pancreatic cancer which is diagnosed by contrast CT. 3)A patient with distal biliary obstruction. 4)A patient >= 20 years old. 5)A patient with performance status of 0-1. 6)Will be followed for 6 months after treatment. 7)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)A patient with hilar biliary obstruction 2)A patient who underwent endoscopic biliary stent placement 3)A patient with duodenal obstruction/stenosis 4)A patient with acute pancreatitis 5)A patient who has a history of reconstruction method other than Billroth 1 anastomosis after gastrectomy. 6)A patient who cannot stop antiplatelet and coagulant drug. 7)A patient with mental disorder 8)A patient with severe organs failure, such as liver, bone marrow, and kidney. ANC = 2.0mg/dL

Design outcomes

Primary

Measure	Time frame
The rate of the occurrence of acute pancreatitis after 7-mm-diamter covered biliary metal stent placement	—

Secondary

Measure	Time frame
The rate of early adverse events, the rate of late adverse events	—

Contacts

Public ContactJunya Sato

Shizuoka Cancer Center

ju.sato@scchr.jp+81-55-989-5222

Outcome results

None listed

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