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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018277
Receipt No. R000021154
Scientific Title A retrospective comparison of the modified Kakita method and the modified Cattel-Warren anastomosis
Date of disclosure of the study information 2015/07/12
Last modified on 2015/07/13

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Basic information
Public title A retrospective comparison of the modified Kakita method and the modified Cattel-Warren anastomosis
Acronym A retrospective comparison of the modified Kakita method and the modified Cattel-Warren anastomosis
Scientific Title A retrospective comparison of the modified Kakita method and the modified Cattel-Warren anastomosis
Scientific Title:Acronym A retrospective comparison of the modified Kakita method and the modified Cattel-Warren anastomosis
Region
Japan

Condition
Condition Biliary tract and pancreas disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study compared the perioperative outcomes from patients who underwent pancreaticojejunostomy in pancreaticoduodenectomy via the modified Kakita method anastomosis (KMA) or the modified Cattell-Warren anastomosis (CWA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of complication
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent pancreaticoduodenectomy
Key exclusion criteria Cases was added to liver resection
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiyoshi Saito
Organization Gunma University, Graduate School of Medicine
Division name Department of General Surgical Science
Zip code
Address 3-39-22 Syouwamachi, Maebashi, Gunma 371-8511, Japan
TEL 080-1024-0132
Email saito_6530@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyoshi Saito
Organization Gunma University, Graduate School of Medicine
Division name Department of General Surgical Science
Zip code
Address 3-39-22 Syouwamachi, Maebashi, Gunma 371-8511, Japan
TEL 080-1024-0132
Homepage URL
Email saito_6530@mac.com

Sponsor
Institute Gunma University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Gunma University, Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2015 Year 07 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective cohort study

Management information
Registered date
2015 Year 07 Month 12 Day
Last modified on
2015 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021154

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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