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A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042260061
Enrollment
30
Registered
2026-06-11
Start date
2026-06-03
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

Malignant hilar biliary stricture cases Malignant hilar biliary stricture

Interventions

Trans-papillary biliary stenting

Sponsors

Okuno Mitsuru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with unresectable malignant hilar biliary obstruction Patients with a pathological diagnosis of malignancy Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP The criteria for abnormal values are as follows: Total bilirubin > 2 mg/dL AST > 45 IU/L ALT > 45 IU/L ALP > 450 IU/L g-GTP > 75 IU/L Patients undergoing initial bilateral inside plastic stent placement Patients expected to have a prognosis of at least 2 months Patients with Bismuth type II-IV (requiring bilateral biliary drainage) Age > 18 years

Exclusion criteria

Exclusion criteria: Patients with concomitant distal biliary obstruction Patients with surgically altered anatomy (excluding Billroth I reconstruction) Patients with severe comorbidities affecting other organs Patients in whom biliary cannulation (transpapillary approach) is not feasible Patients with concomitant duodenal

Design outcomes

Primary

MeasureTime frame
Stent patency duration and stent occlusion rates at 30, 60, and 90 days.

Secondary

MeasureTime frame
Technical and clinical success rates of stent placement Adverse events associated with stent placement Overall survival Details of reintervention at the time of stent occlusion Stent removal success rate Types of stents used during reintervention, and technical and clinical success rates of reintervention Stent patency duration after reintervention

Contacts

Public ContactMitsuru Okuno

Matsunami General Hospital

mkobdkl@yahoo.co.jp+81-58-388-0111

Outcome results

None listed

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