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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007426
Receipt No. R000008519
Scientific Title A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Date of disclosure of the study information 2012/03/02
Last modified on 2014/10/22

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Basic information
Public title A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Acronym A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Scientific Title A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Scientific Title:Acronym A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Region
Japan

Condition
Condition Pancreatic disease required distal pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of clinical pancreatic fistula after distal pancreatectomy between distal duct-to-mucosa pancreaticogastorostomy and pancreatic duct ligation with stump closure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of clinical pancreatic fistula defined by ISGPF (International Study Group Pancreatic Fistula)
Key secondary outcomes Incidence of other postoperative morbidity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Duct-to-mucosa pancreaticogastrostomy after distal pancreaatectomy
Interventions/Control_2 Pancreatic duct ligation with stump closure after distal pancreaatectomy
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 Patients with pancreatic disease requiring distal pancreatectomy
Key exclusion criteria 1, Patients with previous history of gastrectomy
2, Patients requireing combined celiac axis resection
3, Patients requireing subtotal distal pancreatectomy with resection of gastroduodenal artery
4, Patients with active gastric ulcer
5, Patients with total laparoscopic distal pancreatectomyT
6, Patients who were diagnosed inadequacy for this study by a physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Murakami
Organization Hiroshima University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Uemura
Organization Hiroshima University Hospital
Division name Gastrointestinal Surgery
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima, Japan
TEL 082-257-5216
Homepage URL
Email

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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

Other related organizations
Co-sponsor Kansai Medical Univesity Hirakata Hospital

Tohoku Universtiy Hospital
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
2012 Year 03 Month 02 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
2012 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 03 Month 02 Day
Last modified on
2014 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008519

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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