UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062545 |
|---|---|
| Receipt number | R000071593 |
| Scientific Title | A Retrospective Study of Hepatic Artery Resection During Pancreatic Head Resection |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 16:49:51 |
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Basic information
Public title
A Nationwide Multicenter Retrospective Study of Hepatic Artery Resection During Pancreatic Head Resection
Acronym
A Nationwide Multicenter Retrospective Study of Hepatic Artery Resection During Pancreatic Head Resection
Scientific Title
A Retrospective Study of Hepatic Artery Resection During Pancreatic Head Resection
Scientific Title:Acronym
A Retrospective Study of Hepatic Artery Resection During Pancreatic Head Resection
Region
| Japan |
Condition
Condition
Pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the surgical outcomes of hepatic artery resection performed in conjunction with pancreatic head resection, particularly the incidence of postoperative complications and their association with clinical and pathological factors, and to identify the indications and risk factors for hepatic artery resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of complications associated with hepatic artery resection within 90 days postoperatively (intra-abdominal hemorrhage, pseudoaneurysm, hepatic infarction, liver abscess)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which a pancreatic head resection (pancreaticoduodenectomy or total pancreatectomy) combined with hepatic artery resection was performed at institutions participating in the Japanese Society of Pancreatic Surgery between January 1, 2015, and June 30, 2024
Key exclusion criteria
Cases resulting from trauma
Cases involving pancreatectomy with liver resection
Cases in which participation in this study was declined via opt-out
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science
Zip code
930-0194
Address
2630, Sugitani, Toyama-city, Toyama
TEL
0764347331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama-city, Toyama
TEL
0764347331
Homepage URL
fjt@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Center for Clinical Research, Toyama University Hospital
Address
2630, Sugitani, Toyama-city, Toyama
Tel
076-434-7331
rinri@adm.u-toyama.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
| 2026 | Year | 08 | Month | 10 | 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
404
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
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071593
