UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007426 |
|---|---|
| Receipt number | 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 15:03:11 |
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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
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
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008519
