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Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type

Randomized controlled trial of covered metallic stent for malignant lower biliary stricture: Braded vs Laser-cut type - RCT of covered SEMS for MBS: Braded vs Laser-cut type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027239
Enrollment
60
Registered
2017-05-03
Start date
2016-06-01
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

unresected malignancies causing lower or middle biliary stricture

Interventions

Intervention: Laser-cut type of SEMS Control: Braded type of SEMS

Sponsors

Yokohama city university Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients' age of more than 20 years-old. 2) Patients having lower or middle biliary stricture caused by unresectable malignancies 3) Patients having dilation of bile duct and cholangitis, obstructive jaundice or liver dysfunction. 4) Patients who are judged appropriate for endoscopic biliary stenting using metallic stent by chief (responsive) medical examiner. 5) Written informed consent is obtained from patient before the study.

Exclusion criteria

Exclusion criteria: 1) Patients' age of less than 20 years-old. 2) Patients having resectable malignancies. 3) Written informed consent is not obtained from patient before the study. 4) Patients who are judged inappropriate by chief (responsive) medical examiner.

Design outcomes

Primary

MeasureTime frame
rate of stent dysfunction one year after stent intervention

Secondary

MeasureTime frame
safety, success rate, time of stent patency, overall time of survival

Countries

Japan

Contacts

Public ContactTakamitsu Sato

Yokohama City University School of Medicine Department of Gastroenterology and Hepatology

tkmtsato@yokohama-cu.ac.jp+81-45-787-2640

Outcome results

None listed

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