Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial- - Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016513

Enrollment

Registered

2015-02-11

Start date

2015-02-01

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

unresectable distal biliary obstruction

Interventions

Uncovered metallic stent Covered metallic stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Having lower part biliary tract stenosis in the unresectable malignancy. 2. Age is a patient 20 years or older at the agreement acquisition. 3.Patients who understand and are willing to give a written informed consent about participation

Exclusion criteria

Exclusion criteria: 1.Performance Status (PS)4. 2.The patient who has serious disease. 3.The pacient with anticoagulant therapy. 4.The woman becomes pregnant or might be pregnant. 5.The patient who has bile duct stenosis in the liver from a hepatic portal region. 6.Approach from papilla is difficult. 7.Insertion of the endoscope is impossible. 8.Not to include the case that removed duodenal confinement by patient. 9.The patient was judged the physician to be inappropriate.

Design outcomes

Primary

Measure	Time frame
stent patency obstruction rate	—

Countries

Japan

Contacts

Public ContactRyo IGARASHI

Fukushima Medical University Aizu Medical Center gastroenterology

ryo-i@fmu.ac.jp(0242)75-2100

Outcome results

None listed

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