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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033405
Receipt No. R000038079
Scientific Title Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Date of disclosure of the study information 2018/07/18
Last modified on 2018/07/16

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Basic information
Public title Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Acronym Short and Long - Term Outcomes of Choledochojejunostomy: Interrupted Suture versus Continuous Suture.
Scientific Title Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Scientific Title:Acronym Short and Long - Term Outcomes of Choledochojejunostomy: Interrupted Suture versus Continuous Suture.
Region
Japan

Condition
Condition The patients who underwent pancreaticoduodenectomy or total pancreatectomy at Osaka International Cancer Institute.
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the optimal method for choledochojejunostomy by comparing interrupted sutures and continuous sutures. Retrospective analyses using prospectively maintained clinical data base.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes short- and long- term complications related to choledochojejunostomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Choledochojejunostomy performed by interrupted sutures.
Interventions/Control_2 Choledochojejunostomy performed by continuous sutures
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
90 years-old >
Gender Male and Female
Key inclusion criteria The patients who undewent pancreaticoduodenectomy or total pancreatectomy in Osaka International Cancer Institute.
Key exclusion criteria The patients who required extensive resection of the bile duct are not eligible for this analysis.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka International Cancer Institute
Division name Department of Surgery
Zip code
Address 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL 06-6945-1181
Email takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka International Cancer Institute
Division name Department of Surgery
Zip code
Address 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL 06-6945-1181
Homepage URL
Email takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 18 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
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 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

Management information
Registered date
2018 Year 07 Month 16 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038079

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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