UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038239 |
|---|---|
| Receipt number | R000043593 |
| Scientific Title | Efficacy of conversion surgery for locally advanced biliary tract cancer: a multicenter collaborative study |
| Date of disclosure of the study information | 2019/10/09 |
| Last modified on | 2025/04/15 16:06:31 |
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Basic information
Public title
Efficacy of conversion surgery for locally advanced biliary tract cancer: a multicenter collaborative study
Acronym
Efficacy of conversion surgery for locally advanced biliary tract cancer: a multicenter collaborative study
Scientific Title
Efficacy of conversion surgery for locally advanced biliary tract cancer: a multicenter collaborative study
Scientific Title:Acronym
Efficacy of conversion surgery for locally advanced biliary tract cancer: a multicenter collaborative study
Region
| Japan | Asia(except Japan) |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish new evidence by evaluating efficacy and safety of conversion surgery for initially unresectable locally advanced biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence rate, sites of recurrent disease, R0 resection rate, postoperative complications, effects of tumor shrinkage and adverse events induced by preoperative chemo(radio)therapy
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must satisfy all of the following items.
Patients with initially unresectable locally advanced biliary tract cancer including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal bile duct cancer, and gallbladder cancer (diagnosis of resectablility is based on the standard of each participating institution).
Patients who were pathologically diagnosed with biliary tract cancer.
Patients who underwent conversion surgery between January 2013 to December 2017 following chemotherapy or radiotherapy.
Key exclusion criteria
Patients with synchronous multiple cancers.
Patients without completed information on CRFs.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Endo |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
0457872650
endoit@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Yabushita |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
0457872650
Homepage URL
yabu23@yokohama-cu.ac.jp
Sponsor or person
Institute
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Korean Association of Hepato-Biliary-Pancreatic Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9 Fukuura Kanazawaku Yokohama
Tel
0457872800
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JSHBPS-2019-04
Org. issuing International ID_1
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jhbp.1437
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jhbp.1437
Number of participants that the trial has enrolled
56
Results
A total of 56 patients with initially unresectable locally advanced BTC were included. The median time from treatment initiation to surgery was 6.4 months. Severe postoperative complications (Clavien-Dindo grade III or higher) occurred in 34 patients (60.7%), with a mortality rate of 8.9%. A complete pathological response was observed in 8 patients (14.3%). The median overall survival was 37.7 months, and the 3- and 5-year survival rates were 53.9% and 39.1%, respectively.
Results date posted
| 2025 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
conversion surgery in patients with initially unresectable locally advanced biliary tract cancer.
Participant flow
We retrospectively collected clinical data from groups of patients in multiple centers belonging to the Japanese Society of Hepato- Biliary- Pancreatic Surgery and Korean Association of Hepato- Biliary- Pancreatic Surgery.
Adverse events
none
Outcome measures
We analyzed both pretreatment and surgical factors. Pretreatment factors included sex, age, diagnosis, reason for unresectability, radiographic stage according to the Union for International Cancer Control (UICC) Tumor, Node, and Metastasis (TNM) Classification of Malignant Tumors, 8th edition, preoperative treatment, serum carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9) levels, and preoperative treatment response based on the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1. Surgical factors included procedure performed, operation time, intraoperative blood loss, blood transfusion, postoperative complications, and pathological diagnosis. Clinical data including the date of preoperative treatment, surgery, adjuvant therapy, recurrence, last follow-up, and survival status were collected for each patient.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 15 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043593
