UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057044 |
|---|---|
| Receipt number | R000065197 |
| Scientific Title | A retrospective study on the clinical significance of postpancreatectomhy pancreatitis (PPAP) |
| Date of disclosure of the study information | 2025/02/16 |
| Last modified on | 2025/02/16 14:06:58 |
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Basic information
Public title
A retrospective study on the clinical significance of postpancreatectomhy pancreatitis (PPAP)
Acronym
A retrospective study on the clinical significance of postpancreatectomhy pancreatitis (PPAP)
Scientific Title
A retrospective study on the clinical significance of postpancreatectomhy pancreatitis (PPAP)
Scientific Title:Acronym
A retrospective study on the clinical significance of postpancreatectomhy pancreatitis (PPAP)
Region
| Japan |
Condition
Condition
cases undergone pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical significance of postpancreatectomy pancreatitis (PPAP)
Basic objectives2
Others
Basic objectives -Others
To clarify the clinical significance of postpancreatectomy pancreatitis (PPAP)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the postpancreatectomy pancreatitis and the developpement of severe postoperative complications (Clavien-Dindo III or higher)
Key secondary outcomes
1. Frequency of PPAP
2. Correlation between PPAP and clinicopathological factors
3. Identification of risk factors for PPAP
4. Identification of risk factors for severe postoperative complications (Clavien-Dindo III or higher)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergone pancreatoduodenectomy
Key exclusion criteria
1. patients undergone total pancreatectomhy
2. patients undergone simultaneous pancreatoduodenectomy and distal pancreatectomy(tail)
3. patients uncergone hepato-pancreatoduodenectomy
Target sample size
545
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University
Division name
2nd. Department of Surgery
Zip code
6418510
Address
811-1, Kimiidera, Wakayama City, Wakayama
TEL
0734472300
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Shimizu |
Organization
Wakayama Medical University
Division name
2nd. Department of Surgery
Zip code
6418510
Address
811-1, Kimiidera, Wakayama City, Wakayama
TEL
0734472300
Homepage URL
atsus28@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Secretariat, Wakayama Medical University
Address
811-1, Kimidera, Wakayama City, Wakayama
Tel
0734272300
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
| 2025 | Year | 02 | Month | 16 | 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
545
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2025 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065197
