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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020813
Receipt No. R000023859
Scientific Title Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Date of disclosure of the study information 2016/01/31
Last modified on 2016/02/01

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Basic information
Public title Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Acronym Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Scientific Title Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Scientific Title:Acronym Prospective study of postoperative complications in pancreatico-jejunostomy and choledocho-jejunostomy.
Region
Japan

Condition
Condition Hepato-biliary-pancreatic surgery
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate performance of pancreatico-jejunostomy and choledocho-jejunostomy, and to explore improvements.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of Pancreatic fistula
Incidence of Biliary fistula
Key secondary outcomes Complications (incidence, severity, type)
30-day mortality
90-day mortality

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)patients who receive pancreatico-jejunostomy and/or choledocho-jejunostomy.
(2)patients over 20 years old
Key exclusion criteria (1)patients without pancreatico-jejunostomy nor choledocho-jejunostomy.
(2)patients under 19 years old
(3)patients we judge to be inappropriate
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Tohoku University, Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7205
Email kein_h11@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nakagawa
Organization Tohoku University, Graduate School of Medicine
Division name Hepato-biliary-pancreatic surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7205
Homepage URL
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Department of Surgery, Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Tohoku University, Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 31 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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 Patients who are perfomed pancreatico-jejunostomy and/or choledocho-jejunostomy at Hepato-biliary-pancreatic surgery will be enrolled in this study.
Prospectively we record the medical record and inspection numerical values. Each annual, we analize to examine the risk factors for complications.

Management information
Registered date
2016 Year 01 Month 31 Day
Last modified on
2016 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023859

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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