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A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture

A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture - A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005182
Enrollment
200
Registered
2011-04-01
Start date
2011-04-01
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

Advenced biliary tract cancer

Interventions

unilateral drainage bilateral drainage

Sponsors

Kawasaki Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients who have biliary tract carcionoma with type2, 3a, 3b, or 4 hilar biliary stricture according to Bismuth's classification and with abnormal liver function tests 2. The liver funstion tests improve after unirateral drainage with transpapillary endoscopic naso-biliary drainage using plastic stents within four weeks. 3. Biliary tract cancer which is histologically or cytologically proven malignancy 4. Atrophy of the liver is not found due to vascular invasion. 5. Unresectable biriary tract cancer over stage 2b according to TNM classification 6. Patients fully understand and are willing to give a written informed consent about participation.

Exclusion criteria

Exclusion criteria: 1. Performance status is 4. 2. ASA calassification is over 3. 3. Informed consent is not achieved. 4. Patients considered ineligible for this study. 5. The prognosis is considered within three months. 6. Patients who recieved additional treatment after initial unilateral drainage with naso-biliary plastic stents 7. Left or right lobe is occupied by the tumor. 8. Transpapillary deployment of metallic stents is not achieved.

Design outcomes

Primary

MeasureTime frame
duration from stent deployment to re-intervention

Secondary

MeasureTime frame
1. over all survival 2. complication rate 3. rate of stent patency at death 4. rate of application of endoscopic re-intervention to first stent occlusion and success rate of the intervention

Countries

Japan

Contacts

Public ContactHironari Kato

Okayama University Hospital Department of gastroenterology and hepatology

drkatocha@yahoo.co.jp086-235-7219

Outcome results

None listed

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