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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007210
Receipt No. R000008186
Scientific Title A prospective randomized controlled trial. Usefulness of the hepaticoplasty to prevent postoperative cholangitis after pancreaticoduodenectomy.
Date of disclosure of the study information 2012/02/03
Last modified on 2017/11/20

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Basic information
Public title A prospective randomized controlled trial. Usefulness of the hepaticoplasty to prevent postoperative cholangitis after pancreaticoduodenectomy.
Acronym A prospective randomized controlled trial. Usefulness of the hepaticoplasty to prevent postoperative cholangitis after pancreaticoduodenectomy.
Scientific Title A prospective randomized controlled trial. Usefulness of the hepaticoplasty to prevent postoperative cholangitis after pancreaticoduodenectomy.
Scientific Title:Acronym A prospective randomized controlled trial. Usefulness of the hepaticoplasty to prevent postoperative cholangitis after pancreaticoduodenectomy.
Region
Japan

Condition
Condition Periampullary disease required pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the usefulness of the hepaticoplasty in the after pancreaticoduodenectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative cholangitis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Hepaticojejunostomy with hepaticoplasty.
Interventions/Control_2 Hepaticojejunostomy without hepaticoplasty.
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
14 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The cases of pancreaticoduodenectomy for periampullary disease.
Key exclusion criteria Young children.
Pregnancy.
Not agree this study.
Target sample size 70

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masahide Hiyoshi
Organization Miyazaki University School of Medicine
Division name Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki-city, Miyazaki
TEL 0985-85-9284
Email mhiyoshi@med.miyazaki-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masahide Hiyoshi
Organization Miyazaki University School of Medicine
Division name Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki-city, Miyazaki
TEL 0985-85-9284
Homepage URL
Email mhiyoshi@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2012 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S1743919116302916?via%3Dihub
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 Terminated
Date of protocol fixation
2011 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008186

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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