UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030608 |
|---|---|
| Receipt number | R000032361 |
| Scientific Title | Surgical results of intra-pancreatic bile duct resection for biliary malignancy |
| Date of disclosure of the study information | 2017/12/28 |
| Last modified on | 2017/12/28 12:47:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Surgical results of intra-pancreatic bile duct resection for biliary malignancy
Acronym
Intra-pancreatic bile duct resection
Scientific Title
Surgical results of intra-pancreatic bile duct resection for biliary malignancy
Scientific Title:Acronym
Intra-pancreatic bile duct resection
Region
| Japan |
Condition
Condition
Biliary malignancies
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal incidence of pancreatic fistula and recurrence rate after intra pancreatic bile duct resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post operative clinical relevant pancreatic fistula
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with biliary malignancies who underwent surgery in our department from January 2005 to December 2016.
Key exclusion criteria
Patients with pancreaticoduodenectomy
Target sample size
242
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaido University Hospial
Division name
Gastroenterological Surgery II
Zip code
Address
Kita14 Nishi5 Kita-ku Sapporo city
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 Hospital
Division name
Gastroenterological Surgery II
Zip code
Address
Kita14Nishi5 Kita-ku Sapporo city
TEL
011-716-1161
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital Gastroenterokogical Surgery II
Institute
Department
Personal name
Funding Source
Organization
None: self founding
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
m January 2005 until December 2016, there were a total of 493 patients with perihilar or distal cholangiocarcinoma and gallbladder carcinoma with bile duct invasion who underwent several type of surgeries with extrahepatic bile duct resection in our department. Two hundred fifty one patients who performed pancreatoduodenectomy were excluded from this study. Finally, we evaluated 242 patients in this study.
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032361
