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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038239
Receipt No. 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 2020/10/19

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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
Email 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
Email yabu23@yokohama-cu.ac.jp

Sponsor
Institute Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department

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
Email 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
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 No longer recruiting
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
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 10 Month 08 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043593

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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