UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033687 |
|---|---|
| Receipt number | R000024589 |
| Scientific Title | An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture. |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2018/08/07 20:14:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Acronym
An advantage of a triple-row stapler closure in DP
Scientific Title
An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Scientific Title:Acronym
An advantage of a triple-row stapler closure in DP
Region
| Japan |
Condition
Condition
Patients who undergo distal pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove an advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of the incidence of post operative pancreatic fistule after distal pancreatectomy
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
Using a triple-row stapler closure or hand-sewn suture in distal pancreatectomy.
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
Patients who have the planned distal pancreatectomy
Key exclusion criteria
1) Younger than 20years old
2) Patients with febrile
3) No written informed consent of the patients
4) Pregnancy or insufficient contraception
5) Doubtful understanding or contractual capacity of the patient
6)Patients seems inadequate for this study by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kawaida MD PhD |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Surgery
Zip code
Address
1110 Shimokato, Chyuo-shi, Yamanashi
TEL
055-273-7390
hrkawaida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kawaida |
Organization
Faculty of Medicine, University of Yamanashi
Division name
First Department of Surgery
Zip code
Address
1110 Shimokato, Chyuo-shi, Yamanashi
TEL
055-273-7390
Homepage URL
hrkawaida@yahoo.co.jp
Sponsor or person
Institute
First Department of Surgery ,Faculty of Medicine, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2018 | Year | 08 | Month | 08 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024589
