UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017914 |
|---|---|
| Receipt number | R000019949 |
| Scientific Title | Comparison of PD and bile duct resection for middle bile duct cancer (Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?) Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery Biliary part |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/12/18 14:41:15 |
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Basic information
Public title
Comparison of PD and bile duct resection for middle bile duct cancer
(Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?)
Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery
Biliary part
Acronym
Comparison of PD and bile duct resection for middle bile duct cancer
(Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?)
Japan-Korea Collaborative Research
Scientific Title
Comparison of PD and bile duct resection for middle bile duct cancer
(Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?)
Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery
Biliary part
Scientific Title:Acronym
Comparison of PD and bile duct resection for middle bile duct cancer
(Is additional-PD after bile duct segmental resection sufficient to surgical treatment for middle bile duct cancer?)
Japan-Korea Collaborative Research
Region
| Japan | Asia(except Japan) |
Condition
Condition
Middle bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the surgical outcomes of bile duct segmental resection (BDSR) and Pancreaticoduodenectomy (PD) for middle bile duct cancer
To verify whether the additional PD after BDSR to achieve negative bile duct margin have similar survival as straightforward PD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
desease free survival
Key secondary outcomes
Overall survival
R0 resection rate
Morbidity rate
Mortality rate
Recurrence rate
Site of Recurrence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Middle bile duct cancer (definition of middle bile duct cancer is described above)
-Resected between 2001-2010
-Clinically T1, T2, T3 (without invasion to liver parenchyma by preoperative diagnostic imaging and intraoperative macroscopic findings) in TNM 7th classification (ICD-O C24.0) (cT1/2/3 but pT4 cancer should be included)
-M0
-Surgical strategies are defined as bile duct segmental resection (BDSR), pancreaticoduodenectomy including PD, PpPD and SSPPD (PD) and additional PD (AdPD).
Key exclusion criteria
-Bismuth type I hilar cholangiocarcinoma
-cT4 cancer (With invasion to liver parenchyma by preoperative diagnostic imaging and intraoperative macroscopic findings) (cT1/2/3 but pT4 cancer should not be excluded)
-M1 desease
-Preoperative chemotherapy and/or radiation
-With hepatectomy (additional hepatectomy after BDSR or PD is excluded in this study)
-Patient with other cancer within 5-year
Target sample size
3600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7205
Homepage URL
hiroki@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Japanese Ssociety of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Biliary part of Japan-Korea Collaborative Research of Hepato-Biliary-Pancreatic Surgery
Biliary part
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019949
