UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033848 |
|---|---|
| Receipt number | R000038601 |
| Scientific Title | The superiority of reinforced stapler compared to bare triple row stapler in Distal Pancreatectomy. |
| Date of disclosure of the study information | 2018/08/21 |
| Last modified on | 2024/02/24 10:03:41 |
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Basic information
Public title
The superiority of reinforced stapler compared to bare triple row stapler in Distal Pancreatectomy.
Acronym
Reinforced stapler in Distal Pancreatectomy.
Scientific Title
The superiority of reinforced stapler compared to bare triple row stapler in Distal Pancreatectomy.
Scientific Title:Acronym
Reinforced stapler in Distal Pancreatectomy.
Region
| Japan |
Condition
Condition
Pancreatic body and tail tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the superiority of reinforced stapler compared to bare triple row stapler.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of pancreatic fistula grade B and grade C based on International Study Group of Postoperative Pancreatic Fistula(ISGPF)
Key secondary outcomes
1)Morbidity
2)Mortality
3)Postoperative hospital stay
4)Relationship between BMI and occurrence of pancreatic fistula
5)The frequency of occurrence of delayed gastric empty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The Endo GIA Reinforced Reload with Tri-Staple technology
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) Disease of pancreatic body and tail
2) PS (ECOG Performance Status Scale)0-1
3) Age: 20 years or older
4)Patients who can provide written informed consent
Key exclusion criteria
1) Patients with severe ischemic cardiac disease
2) Patients with severe liver cirrhosis or active hepatitis
3) Patients with respiratory illness that requires oxygen administration
4) Patients with chronic renal failure requiring peritoneal dialysis
5) Patients who are unfit for the study as determined by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ichikawa |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Surgery
Zip code
409-3821
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-7390
dichikawa@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Kawaida |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Surgery
Zip code
409-3821
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-7390
Homepage URL
kawaidah@yamanashi.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
None
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
Faculty of Medicine, University of Yamanashi
Address
1110 Shimokato, Chuo, Yamanashi
Tel
055-273-7390
kawaidah@yamanashi.ac.jp
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
| 2018 | Year | 08 | Month | 21 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038601
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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