UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051587 |
|---|---|
| Receipt number | R000058857 |
| Scientific Title | Study of the Effect of Anti-adhesive Agents on Liver Resection |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2024/12/04 13:46:21 |
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Basic information
Public title
Study of the Effect of Anti-adhesive Agents on Liver Resection
Acronym
Study of the Effect of Anti-adhesive Agents on Liver Resection
Scientific Title
Study of the Effect of Anti-adhesive Agents on Liver Resection
Scientific Title:Acronym
Study of the Effect of Anti-adhesive Agents on Liver Resection
Region
| Japan |
Condition
Condition
Primary and metastatic liver cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate how anti-adhesion materials affect post-operative complications and repeat hepatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical time for rehepatectomy
Key secondary outcomes
Recurrence-free survival, cumulative overall survival, postoperative complications according to Calvien-Dindo classification
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who underwent hepatic resection and received anti-adhesive material during the period 1990-2020
Interventions/Control_2
Patients who underwent hepatic resection during the period 1990-2020 and were not given anti-adhesive material
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients 85 years of age or younger who are judged to be eligible for hepatic resection
2) Cases in which liver resection was performed after obtaining consent
(3) Cases in which it is known whether or not anti-adhesion material was administered.
Key exclusion criteria
(1)Those who have refused to allow their personal data to be used in any research
(2)Persons who have refused to participate in this research
(3)Other persons who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
1738610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
+81-3-3972-8111
nakayama.hisashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
1738610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
+82-3-3972-8111
Homepage URL
nakayama.hisashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon Universtiy
Institute
Department
Personal name
Funding Source
Organization
no
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
Nihon University School of Medicine Itabashi Hospital
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
Tel
+81-3-3972-8111
nakayama.hisashi@nihon-u.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
| 2023 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | 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
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058857
