Comparison of bilateral and bilateral with tri-segmental endoscopic drainage for high-grade malignant hilar biliary obstructions

JRCT ID: jRCTs062220038

Registered date:23/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: High-grade malignant hilar biliary obstructions
• Date of first enrollment: 15/08/2022
• Target sample size: 76
• Study type: Interventional

Intervention(s)

Two SEMS (Self Expandable Metallic Stent) group
Three SEMS (Self Expandable Metallic Stent) group

Outcome(s)

• Primary Outcome: non-recurrent biliary obstruction (non-RBO) rate
• Secondary Outcome: Technical Success, Clinical Success, Time to RBO, Cause of RBO, Complications other than RBO, Duration of procedure, Time to RBO by EST, Overall Survival, Technical Success and Clinical Success at Re-intervention

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Unresectable malignant hilar biliary obstructions with Bismuth type IIIa or IV
2. Age over 18
3. Patient with fully informed consent

Exclude criteria

1. Reconstructed bowel other than Billroth 1
2. Inferior border of the biliary stricture extends close to the duodenal papilla which required stenting across the papilla Vater.
3. Endoscopic drainage will be ineffective due to severely divided bile duct, or severe portal vein invasion due to multiple liver metastasis. .
4. Radical resection, radiation therapy, and proton/particle therapy will be planned
5. Patient with pregnant or possibly pregnant.
6. Patient who are not expected to live 1 month or longer
7. Patient judged by the investigator to be inappropriate to enroll.

Related Information

• Primary Sponsor: Kato Hironari
• Source(s) of Monetary Support: Zeon Medical Inc.