UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044297 |
|---|---|
| Receipt number | R000050601 |
| Scientific Title | Risk stratification for clinically relevant pancreatic fistula in early drain removal with higher drain fluid amylase following pancreaticoduodenectomy |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2023/05/25 09:57:01 |
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Basic information
Public title
Risk stratification for clinically relevant pancreatic fistula in early drain removal with higher drain fluid amylase following pancreaticoduodenectomy
Acronym
Risk stratification for clinically relevant pancreatic fistula in early drain removal with higher drain fluid amylase following pancreaticoduodenectomy
Scientific Title
Risk stratification for clinically relevant pancreatic fistula in early drain removal with higher drain fluid amylase following pancreaticoduodenectomy
Scientific Title:Acronym
Risk stratification for clinically relevant pancreatic fistula in early drain removal with higher drain fluid amylase following pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
patients who underwent pancreatic head resection for peripancreatic disease between January 2015 and December 2020
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the risk factors of clinically relevant pancreatic fistula development after early drain removal following pancreaticoduodenectomy in higher drain fluid amylase.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the risk factors of clinically relevant pancreatic fistula development after early drain removal following pancreaticoduodenectomy in higher drain fluid amylase
Key secondary outcomes
the incidence of clinically relevant pancreatic fistula in higher drain fluid amylase
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent pancreatic head resection for peripancreatic disease
Key exclusion criteria
1.case with late drain removal
2.case with missing data of drain fluid amylase on postoperative day1 and day3
Target sample size
364
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama, Japan
TEL
0734410613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama, Japan
TEL
0734410613
Homepage URL
kawai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama, Japan
Tel
0734472300
wa-rinri@wakayama-med.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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 25 | 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
364
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
| 2021 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The cohort study has been conducted to evaluate whether early removal drain in higher drain fluid amylase( more than 4,000U/L)on POD1 affects the development of clinically relevant pancreatic fistula after pancreaticoduodenectomy. The aim of this study is to clarify the risk factors of clinically relevant pancreatic fistula development after early drain removal following PD in higher drain fluid amylase.
Management information
Registered date
| 2021 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050601
| 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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| Registered date | File name |
