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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030608
Receipt No. 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

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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
Email 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
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital Gastroenterokogical Surgery II
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032361

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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