UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047580 |
|---|---|
| Receipt number | R000054258 |
| Scientific Title | Covering reinforced staples with polyethylene glycolic acid felt-covered fibrin sealant to prevent pancreatic fistulas after distal pancreatomy : a retrospective comparative study |
| Date of disclosure of the study information | 2022/04/24 |
| Last modified on | 2022/04/24 21:49:13 |
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Basic information
Public title
Covering reinforced staples with polyethylene glycolic acid felt-covered fibrin sealant to prevent pancreatic fistulas after distal pancreatomy : a retrospective comparative study
Acronym
Covering reinforced staples with polyethylene glycolic acid felt-covered fibrin sealant to prevent pancreatic fistulas after distal pancreatomy : a retrospective comparative study
Scientific Title
Covering reinforced staples with polyethylene glycolic acid felt-covered fibrin sealant to prevent pancreatic fistulas after distal pancreatomy : a retrospective comparative study
Scientific Title:Acronym
Covering reinforced staples with polyethylene glycolic acid felt-covered fibrin sealant to prevent pancreatic fistulas after distal pancreatomy : a retrospective comparative study
Region
| Japan |
Condition
Condition
pancreatic fistula after distal pancreatomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed the treatment of pancreatic stump in distal pancreatomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usefulness of PPF method for postoperative pancreatic fistulas in distal pancreactomy.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From January 2008 to June 2021, we included 127 cases of distal pancreactomy in our department
Key exclusion criteria
N/A
Target sample size
127
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayashi |
Organization
Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
Division name
Department of General Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-323-5111
tatsuya_hayashi@tmhp.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Kawasaki |
Organization
Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
Division name
Department of General Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-323-5111
Homepage URL
kkawasaki1231@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
Tel
042-323-5111
kkawasaki1231@gmail.com
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
| 2022 | Year | 04 | Month | 24 | 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
127
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
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 04 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054258
