UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032402 |
|---|---|
| Receipt number | R000036954 |
| Scientific Title | The impact of pancreatic duct stent in pancreatic fistula following pancreaticoduodenectomy;retrospective large observational study by Japan-Korean project |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2021/01/07 09:41:46 |
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Basic information
Public title
The impact of pancreatic duct stent in pancreatic fistula following pancreaticoduodenectomy;retrospective large observational study by Japan-Korean project
Acronym
The impact of pancreatic duct stent in pancreatic fistula after pancreaticoduodenectomy
Scientific Title
The impact of pancreatic duct stent in pancreatic fistula following pancreaticoduodenectomy;retrospective large observational study by Japan-Korean project
Scientific Title:Acronym
The impact of pancreatic duct stent in pancreatic fistula after pancreaticoduodenectomy
Region
| Japan | Asia(except Japan) |
Condition
Condition
patients who underwent pancreaticoduodenectomy for periampullary lesion
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this multicenter large cohort study was to clarify which pancreatic stent is more effective between internal stent and external stent to reduce clinically relevant pancreatic fistula after pancreaticoduodenectomy (PD).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of pancreatic fistula classified by the International Study Group of Pancreatic Fistula(ISGPF) between internal stent and external stent
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
2) Age: 20 years or older
Key exclusion criteria
patients who are unfit for this study as determined by the attending physician
Target sample size
3000
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, 641-8510
TEL
073-441-0613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Second Department of Surgery, Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan, 641-8510
TEL
0734410613
Homepage URL
kawai@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
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, 641-8510
Tel
073-447-2300
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://wakayama-med-2ndsurg.jp/news/
Publication of results
Published
Result
URL related to results and publications
https://wakayama-med-2ndsurg.jp/news/
Number of participants that the trial has enrolled
3149
Results
clinically relevant pancreatic fistula occurred in more patients in the external stents group (280 patients, 28.7%) than in patients in the internal stents group (126 patients, 12.9%) (OR 2.713 [95% CI, 2.139e3.455]; P < 0.001).
Results date posted
| 2021 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
3149 patients who underwent　PD at 20 institutions in Japan and Korea between 2007 and 2013.
Participant flow
End of follow-up
Adverse events
none
Outcome measures
The primary endpoint was the incidence of clinically relevant pancreatic fistula
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Between 2007 and 2013, 3,149 patients (internal stent and external stent) who underwent PD at 20 institutions in Japan and Korea are reviewed. Propensity score matched analysis is used to minimize bias from nonrandomized treatment assignment. The primary endpoint was the incidence of clinically relevant pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria.
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036954
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