UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054714 |
|---|---|
| Receipt number | R000062526 |
| Scientific Title | Prospective Registry Of Robotic liver resection in Kyoto university hepato-biliary-pancreatic surgery (KUHPBS) group: A multicenter prospective cohort analysis |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/12/19 12:53:38 |
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Basic information
Public title
Prospective Registry Of Robotic liver resection in Kyoto university hepato-biliary-pancreatic surgery (KUHPBS) group
Acronym
PROROBO-LIVER study
Scientific Title
Prospective Registry Of Robotic liver resection in Kyoto university hepato-biliary-pancreatic surgery (KUHPBS) group: A multicenter prospective cohort analysis
Scientific Title:Acronym
PROROBO-LIVER study
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this multicenter prospective cohort study is to assess the safety of robotic liver resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are intraoperative blood loss, operation time, conversion to open surgery, and intraoperative accidents.
Key secondary outcomes
The secondary endpoints are postoperative complications, re-operation, and length of hospital stay after surgery.
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
The study includes 20-year-olds and older people who undergo the robotic liver resection and have given written informed consent.
Key exclusion criteria
Exclusion criteria were as follows: (1)liver resection with vascular or bile duct reconstruction, (2) being difficult to obtain consent for explanations, such as consciousness levels and examples of cognitive decline, and (3) written consent being not obtained. The number of such patients is reported separately.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Fujikawa |
Organization
Kokura Memorial Hospital
Division name
Surgery
Zip code
8028555
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
TEL
0935112000
fujikawa-t@kokurakinen.or.jp
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
Department of Surgery, Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kokura Memorial Hospital
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
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, JAPAN
Tel
0935112000
rinsyo@kokurakinen.or.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
| 2024 | Year | 06 | Month | 19 | 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
| 2024 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients undergoing robotic liver resection are informed of the procedure and obtain their approval. They are registered in this study. They are observed from surgery until discharge. During this observation period, we will investigate the patient's background, the surgical procedure, perioperative complications, and the prognosis.
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062526
