Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial- - Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015093

Enrollment

Registered

2014-10-01

Start date

2014-04-01

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; an adaptation patient of endoscopic retrograde bile duct pancreatic duct contrasting (ERCP). 2. It can be indicated the art of endoscopic duodenal nipple incision and drainage, and an agreement is provided when it enforces it again. 3. When I perform a pathological search and get a malignant definitive diagnosis, or a malignancy is diagnosed by an image and hematologic inspection clinically even if I perform a pathological search when a malignant diagnosis is difficult. 4.Performance status is a patient of 0-2. 5.Having chemoradiation treatment combination or not does not matter. 6.Age is a patient 20 years or older at the agreement acquisition. 7.A document agreement by the free will of the patient person is provided in the one which understands enough it after having received enough explanation on participating of the final examination case 8 within 30th from the first drainage. 9.I am limited to a patient admitted to other Houses after hospitalization or treatment.

Exclusion criteria

Exclusion criteria: 1.The patient who has bile duct stenosis in the liver from a hepatic portal region. 2.A state is extremely bad from head to foot. 3.) not to include the case that removed duodenal confinement by patient (Stent or the operation that duodenal 3rd portion blocked up. 4. The patient who cannot agree to endoscopic retrograde bile duct pancreatic duct contrasting (ERCP) or endoscopic treatment (endoscopic nipple incision, art of drainage). 5.The patient with the allergy to metal. 6.A patient with a history of the custody of the past metallic stent. 7.A patient considered to be below 30 days in convalescence.

Design outcomes

Primary

Measure	Time frame
stent patency obstruction rate	—

Countries

Japan

Contacts

Public ContactYuji Sakai

Chiba Univeresity Gastroenterology

sakai4754@yahoo.co.jp81-43-2262083

Outcome results

None listed

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