Tokyo, Dec. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060060) titled 'Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction' on Dec. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Ise Red Cross Hospital
Condition:
Condition - unresectable malignant hilar biliary obstruction
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively evaluate the efficacy of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - patients who underwent the first biliary drainage with a permanent stent for unresectable malignant hilar biliary obstruction classified as Bismuth type I-III
Key exclusion criteria - 1) Patients who had undergone upper gastrointestinal reconstruction other than Billroth I
2) Patients after bilioenteric anastomosis
3) Patients in whom clinical success is not expected by stent placement
4) Patients with temporary biliary drainage
5) Patients with transpapillary biliary stent placement and biliary-enteric anastomosis
6) Patients undergoing tumor ablation for biliary stricture
7) Patients with history or presence of benign biliary stricture
8) Pregnant patients
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 07 Day
Date of IRB - 2025 Year 10 Month 07 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2028 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068686
Disclaimer: Curated by HT Syndication.
