UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055072 |
|---|---|
| Receipt number | R000062917 |
| Scientific Title | Safety and feasibility of robotic liver resection utilizing saline-linked cautery technique: A propensity score-matched analysis |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2024/07/25 14:56:51 |
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Basic information
Public title
Safety and feasibility of robotic liver resection utilizing saline-linked cautery technique: A propensity score-matched analysis
Acronym
Safety and feasibility of robotic liver resection utilizing saline-linked cautery technique: A propensity score-matched analysis
Scientific Title
Safety and feasibility of robotic liver resection utilizing saline-linked cautery technique: A propensity score-matched analysis
Scientific Title:Acronym
Safety and feasibility of RLR utilizing SLiC technique: A PSM analysis
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Liver parenchymal transection is still the most difficult aspect of robotic liver resection due to the limitations of the currently available robotic instruments and the lack of a standardized method. The safety and practicality of the saline-linked cautery method for robotic liver resection were verified by comparing the perioperative outcomes of robotic liver resection with laparoscopic liver resection using propensity score-matching.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative outcomes (operation time, blood loss, intraoperative accident, postoperative complication, transfusion, length of stay, mortality)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consent to participate in clinical research for scheduled surgery
Key exclusion criteria
Consent to participate in clinical research has not been obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Uemoto |
Organization
Kokura memorial hospital
Division name
Surgery
Zip code
8028555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0935112000
uemoto0522@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Uemoto |
Organization
Kokura Memorial Hospital
Division name
Surgery
Zip code
8028555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0935112000
Homepage URL
uemoto0522@gmail.com
Sponsor or person
Institute
Kokura momorial hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
Tel
0935112000
uemoto0522@gmail.com
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
| 2024 | Year | 07 | Month | 25 | 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
221
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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We verified the safety and practicality of robotic liver resection by comparing the perioperative outcomes of robotic liver resection with laparoscopic liver resection. Although it was a single-center, retrospective study, the verification was conducted between matched groups using propensity score-matching.
Management information
Registered date
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062917
