UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052036 |
|---|---|
| Receipt number | R000059394 |
| Scientific Title | Efficacy of horizontal mattress suture for prevention of pancreatic fistula after distal pancreatectomy: clinical study |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/08/29 10:34:54 |
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Basic information
Public title
Efficacy of horizontal mattress suture for prevention of pancreatic fistula after distal pancreatectomy: clinical study
Acronym
Prevention of pancreatic fistula by horizontal mattress suture after distal pancreatectomy
Scientific Title
Efficacy of horizontal mattress suture for prevention of pancreatic fistula after distal pancreatectomy: clinical study
Scientific Title:Acronym
Prevention of pancreatic fistula by horizontal mattress suture after distal pancreatectomy
Region
| Japan |
Condition
Condition
Tumors in the body or tail of the pancreas
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of horizontal mattress suture for prevention of pancreatic fistula after distal pancreatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Postoperative pancreatic fistula and its GRADE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard treatment group (automatic suturing device)
Interventions/Control_2
Trial therapy group (horizontal mattress suture)
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) Patients scheduled for open or robotic-assisted distal pancreatectomy for disease of the body or tail of the pancreas
2) Age over 20 years old on the day of surgery
3) Those whose written consent has been obtained
Key exclusion criteria
1) Patients who are scheduled to resect other organs (except gallbladder)
2) Patients scheduled for laparoscopic distal pancreatectomy not performed under robotic assistance
3) Patients undergoing residual total pancreatectomy
4) Patients undergoing distal pancreatectomy with celiac axis resection
5) Patients who have severe comorbidity
6) Patients during pregnancy or at risk of becoming pregnant
7) Others patients considered inappropriate by the study investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kobayashi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
5650871
Address
2-2-E2,Suita yamadaoka, Osaka, 565-0871, Japan
TEL
06-6879-3251
skobayashi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kobayashi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
5650871
Address
2-2-E2,Suita yamadaoka, Osaka, 565-0871, Japan
TEL
06-6879-3251
Homepage URL
skobayashi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
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
Osaka University Hospital Ethics Review Committee
Address
4F, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059394
