UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035900 |
|---|---|
| Receipt number | R000040903 |
| Scientific Title | Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study |
| Date of disclosure of the study information | 2019/02/17 |
| Last modified on | 2019/02/17 08:29:28 |
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Basic information
Public title
Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study
Acronym
Conversion surgery for biliary malignancy
Scientific Title
Conversion surgery for initially unresectable biliary malignancies: A multicentre retrospective cohort study
Scientific Title:Acronym
Conversion surgery for biliary malignancy
Region
| Japan |
Condition
Condition
Biliary malignancy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility of surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 year survival
Key secondary outcomes
Post operative complications
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
1) presence of initially unresectable biliary cancer; and 2) having undergone radical surgical resection following the achievement of stable disease (SD), partial response (PR) or complete response (CR) over three months
Key exclusion criteria
Data missing
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hokkaido University |
Organization
Faculty of Medicine
Division name
Gastroenterological surgery II
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL
011-716-1161
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaido University
Division name
Faculty of Medicine, Gastroenterological surgery II
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido Japan
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido univeristy gastroenterological surgery II
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
| 2019 | Year | 02 | Month | 17 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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
Six of nine training institutes for highly advanced surgery, registered by the committee of Japanese Society of Hepato-Biliary-Pancreatic Surgery (in Hokkaido), are participants of the HOCS group. A multicentre survey was conducted by the HOCS group for the collection of clinical data on patients who underwent conversion surgery, from January 2005 to December 2017.
Management information
Registered date
| 2019 | Year | 02 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040903
