Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma

Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma - Large-bore metal stent study (LBM study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031110

Enrollment

Registered

2019-01-01

Start date

2018-02-12

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

Unresectable pancreatic cancer with malignant biliary obstruction

Interventions

New designed large-bore, fully covered self-expandable metallic stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable pancreatic cancer with distal malignant biliary obstruction. 2) Patients with predictable prognosis of more than 4 months. 3) Patients with written informed consent. 4) Patients with performance status 0-3.

Exclusion criteria

Exclusion criteria: 1) Patients with massive ascites. 2) Patients with severely impaired organ function. 3) Patients for whom endoscopic biliary drainage is difficult. 4) Patients with duodenal obstruction. 5) Patients whose antithrombotic drugs cannot be stopped. 6) Patients considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
Time to stent dysfunction	—

Secondary

Measure	Time frame
Effectiveness 1) Stent patency period 2) Survival period 3) Event free survival 4) Stent patency period after reintervention 5) Time to stent dysfunction after reintervention 6) Cost effectiveness Safety 1) Early complications 2) Late complications 3) Technical success rate 4) Removability of the stent 5) Removability of the second stent	—

Countries

Japan

Contacts

Public ContactAkira Kurita

Kitano Hospital, Tazuke Kofukai Medical Research Institute Department of Gastroenterology and Hepatology

kuritaaki1976@gmail.com06-6312-8831

Outcome results

None listed

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