UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061093 |
|---|---|
| Receipt number | R000069908 |
| Scientific Title | A study of surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma |
| Date of disclosure of the study information | 2026/03/28 |
| Last modified on | 2026/03/28 17:48:28 |
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Basic information
Public title
A study of surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma
Acronym
A study of surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma
Scientific Title
A study of surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma
Scientific Title:Acronym
surgical treatment as conversion therapy for initially unresectable biliary tract carcinoma
Region
| Japan |
Condition
Condition
biliary tract carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
An analysis of prognostic factors based on preoperative clinicophysiological and pathological variables in patients undergoing conversion surgery.
Key secondary outcomes
1,Evaluation of the relationship between the duration of preoperative therapy and prognosis in patients undergoing conversion surgery
2,Evaluation of the relationship between preoperative treatment and prognosis in patients undergoing conversion surgery
3,Evaluation of the relationship between factors rendering the tumor initially unresectable and prognosis in patients undergoing conversion surgery
4,Evaluation of the relationship between disease-specific factors and prognosis in patients undergoing conversion surgery
Exploratory endpoints:
A comparative analysis will be performed between pre-treatment and preoperative clinicophysiological factors in patients undergoing conversion surgery to investigate their association with prognosis. In addition, correlations with postoperative pathological factors will be assessed.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Suzuki |
Organization
Ibaraki medical center, Tokyo Medical University
Division name
Gastroenterological Surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashikigunn,Ibaraki, Japan
TEL
0298871161
ssuzuki@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyamoto |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashikigunn,Ibaraki, Japan
TEL
029-887-1161
Homepage URL
miyamoto.ryoichi.7p@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Shuji Suzuki
Funding Source
Organization
Japan biliary association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Ethics Review Committee
Address
6-7-1,Nishishinjyuku,,Shinjyuku-ku,Tokyo,Japan
Tel
03-3342-6111
Adm_IRB@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科大学茨城医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected samples and data
1,Basic patient characteristics(age, sex, height, body weight, lifestyle habits, region of birth, etc.)
2,Information on diagnosis, disease severity, and disease progression
3,Results of pre-treatment examinations (blood, urine, and imaging tests)
4,Details of preoperative treatment, therapeutic response, and duration
5,Results of preoperative examinations (blood, urine, and imaging tests)
6,Details of the surgical resection procedure
7,Presence or absence of postoperative complications (Clavien Dindo classification)
8,Post-resection clinicopathological factors (histological grade, subtype classification, pathological response classification, TNM classification)
9,Presence or absence of adjuvant chemotherapy, including regimen and duration
10,Prognostic information (site of recurrence, progression-free survival, overall survival)
Management information
Registered date
| 2026 | Year | 03 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069908
