Tokyo, March 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061093) titled 'A study of surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma' on March 28.
Study Type:
Observational
Primary Sponsor:
Institute - Tokyo Medical University
Condition:
Condition - biliary tract carcinoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Although biliary tract carcinoma is one of the malignancies with a very poor prognosis, recent advances in chemotherapy and radiotherapy have enabled conversion surgery to be performed in some patients with initially unresectable disease. However, the number of cases undergoing conversion surgery remains limited at individual institutions, and the factors enabling conversion surgery as well as the relationship between the duration of preoperative treatment and prognosis have yet to be fully elucidated. To date, no nationwide study addressing these issues in patients with initially unresectable biliary tract cancer has been conducted in Japan.
The aim of this study is to conduct a nationwide analysis of cases from institutions accredited by the Japanese Society of Biliary Surgery and to clarify the clinical utility of conversion surgery, as well as the optimal timing for conversion, in patients with initially unresectable biliary tract carcinoma in Japan.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1,Patients aged over 20 years with initially unresectable biliary tract carcinoma who underwent preoperative treatment and subsequently became eligible for surgical resection
2,Patients with available preoperative clinicophysiological data and resected clinicopathological findings
Key exclusion criteria - 1,Patients who did not have initially unresectable biliary tract carcinoma
2,Patients who declined to participate in the study
Target Size - 270
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 21 Day
Date of IRB - 2026 Year 01 Month 21 Day
Anticipated trial start date - 2026 Year 01 Month 30 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069908
Disclaimer: Curated by HT Syndication.