UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056659 |
|---|---|
| Receipt number | R000064759 |
| Scientific Title | Compression evaluation of pancreatic specimens to develop a stapler device to prevent pancreatic fistula |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/01/08 05:40:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Compression evaluation of pancreatic tissue for the development of a stapler device to prevent pancreatic fluid leaks
Acronym
The development of a stapler device to prevent pancreatic fluid leaks
Scientific Title
Compression evaluation of pancreatic specimens to develop a stapler device to prevent pancreatic fistula
Scientific Title:Acronym
Compression evaluation of pancreatic specimens to develop a stapler device to prevent pancreatic fistula
Region
| Japan |
Condition
Condition
Borderline malignant pancreatic diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the physical and histological changes occurring in pancreatic tissue during distal pancreatectomy, and to elucidate the conditions under which pancreatic fistula develops.
Basic objectives2
Others
Basic objectives -Others
Elastic modulus during pancreatic compression, fracture energy, pancreatic thickness, and histological evaluation post-compression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elastic modulus, fracture energy, pancreatic thickness during pancreatic compression, and histological evaluation post-compression
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. Borderline malignant pancreatic diseases.
2. Preoperative examinations suggest sufficient research specimens can be collected after resecting the lesion.
3. An adequate explanation of the subject's research participation and written informed consent (IC) has been obtained.
Key exclusion criteria
1. Malignant pancreatic diseases.
2. Cases requiring pathological evaluation of the pancreatic body and tail to assess the extent of the lesion.
3. Unsuitable patient at a physician's decision.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-3815-5411
hasegawa-2su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Takayama |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-3815-5411
Homepage URL
takayamam-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who visited our institution during the study period and met the inclusion criteria are included in the analysis.
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064759
