UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062618 |
|---|---|
| Receipt number | R000071672 |
| Scientific Title | Robotic versus Laparoscopic Liver Resection fro Liver Tumors: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/19 17:51:01 |
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Basic information
Public title
Robotic versus Laparoscopic Liver Resection fro Liver Tumors: A Multicenter Randomized Controlled Trial
Acronym
Robotic versus Laparoscopic Liver Resection fro Liver Tumors: A Multicenter Randomized Controlled Trial
Scientific Title
Robotic versus Laparoscopic Liver Resection fro Liver Tumors: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
ROBOLIVER Trial
Region
| Japan |
Condition
Condition
Liver tumors (benign, borderline malignant, or malignant)
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the superiority of complication rate more than Clavien-Dindo grade II occurring within 30 days after surgery in robotic liver resetion compared to laparoscopic liver resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Complication rate more than Clavien-Dindo grade II occurring within 30 days after surgery
Key secondary outcomes
1. Operating time
2. Total time of Pringle maneuver
3. Intraoperative blood loss
4. Amount of intraoperative transfusion
5. Conversion rate
6. Dischargability
7. Comprehensive complication index
8. Intraoperative complication rate
9. Late complication rate
10. Readmission rate within 90 days after surgery
11. R0 resection rate, mortality
12. Surgeon's stress evaluated by ActiGraph LEAP and SURG-TLX
13. Medical cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robotic liver resection
Interventions/Control_2
laparoscopic liver resection
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with suspected or histologically confirmed primary or metastatic liver tumors who are scheduled to undergo elective minimally invasive anatomical liver resection (RLR/LLR) with or without cholecystectomy.
Trisectionectomy
Hemihepatectomy or extended hemihepatectomy
Central bisectionectomy
Sectionectomy (posterior, anterior, or medial sectionectomy)
Segmentectomy (Couinaud segments 1, 2, 3, 4, 5, 6, 7, and 8)
2. Age between 18 and 84 years at the time of consent acquisition.
3. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0, 1, or 2.
4. Written informed consent obtained from the patient before enrollment.
Key exclusion criteria
1. Requirement for concomitant biliary reconstruction.
2. Requirement for concomitant resection of other organs, except for cholecystectomy.
3. Requirement for lymph node dissection
4. Known allergy or hypersensitivity to indocyanine green.
4. Pregnant or breastfeeding women, women within 28 days postpartum, or women with possible pregnancy.
5. Severe psychiatric disorder or cognitive impairment that may interfere with study participation or protocol compliance.
6. Severe uncontrolled systemic disease or active infection judged by the investigators to make participation inappropriate.
7. Any other condition that, in the opinion of the investigators, would render the patient unsuitable for enrollment in the trial.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Wakabayashi |
Organization
Ageo Central General Hospital
Division name
Center for Advanced Treatment of Hepatobiliary and Pancreatic Diseases
Zip code
362-8588
Address
1-10-10, Kashiwaza, Ageo city, Saitama
TEL
048-773-1111
gowaka@ach.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nitta |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
0196137111
Homepage URL
hnitta@iwate-med.ac.jp
Sponsor or person
Institute
Endoscopic Liver Surgery Study Group
Institute
Department
Personal name
Funding Source
Organization
Endoscopic Liver Surgery Study Group
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
Iwate Medical Univerisity
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
Tel
0196137111
aumemura@iwate-med.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 | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071672
