UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058846 |
|---|---|
| Receipt number | R000067273 |
| Scientific Title | Evaluation of the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/20 12:19:35 |
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Basic information
Public title
A study to evaluate the safety of robotic-assisted liver resection, including bile duct resection and biliary reconstruction
Acronym
Safety study of robotic-assisted liver resection, including bile duct resection and biliary reconstruction
Scientific Title
Evaluation of the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction
Scientific Title:Acronym
Evaluation of the safety of robotic-assisted hepatectomy with bile duct resection and biliary reconstruction
Region
| Japan |
Condition
Condition
Patients diagnosed by contrast-enhanced CT or MRI with primary liver cancer, metastatic liver cancer, perihilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, or benign tumors such as hemangioma, for whom liver resection, as well as bile duct resection and biliary reconstruction, is deemed necessary.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical trial is to evaluate the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All intraoperative and postoperative complications of Clavien-Dindo grade 3 or higher
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
This clinical trial aims to evaluate the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction. For the eligible disease, surgery will be performed using the da Vinci Xi system, and intraoperative and postoperative complications will be observed.
If a patient is deemed eligible for this study, the principal investigator or sub-investigators will explain the study in the outpatient setting using an informed consent document approved by the Keio University School of Medicine Ethics Committee. The advantages and disadvantages of robotic-assisted surgery will be thoroughly explained, and sufficient time will be provided for the patient to consider whether they wish to undergo this protocol treatment.
Preoperative assessment, including evaluation of liver function, will be performed. Postoperative management will continue until discharge, regardless of the presence or absence of complications, following standard surgical care.
For each case, a Safety Evaluation Committee, including a board-certified hepatobiliary-pancreatic surgeon and an external physician recommended by the Japanese Society of Gastroenterological Surgery or the Japanese Society of Hepato-Biliary-Pancreatic Surgery, will review whether the clinical trial was conducted according to protocol. Additionally, the next patient will not be enrolled until the evaluation report for the previous case is completed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed by contrast-enhanced CT, MRI, or similar imaging modalities with primary liver cancer, metastatic liver cancer, perihilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, or benign tumors such as hemangioma.
2) Patients for whom liver resection, as well as bile duct resection and biliary reconstruction, is deemed necessary.
3) Age 18 years or older at the time of consent.
4) Written informed consent to participate in this clinical trial has been obtained from the patient.
5) ECOG performance status of 0 or 1.
Key exclusion criteria
1) Patients with a history of myocardial infarction within the past 6 months or with unstable angina.
2) Patients with alcohol or drug dependence.
3) Pregnant or breastfeeding women, or women with potential for pregnancy.
4) Patients with respiratory diseases requiring continuous oxygen therapy.
5) Patients judged by anesthesiology to be unfit for general anesthesia.
6) Patients with synchronous multiple primary cancers.
7) Patients requiring vascular resection and reconstruction.
8) Patients judged to be at high surgical risk due to uncontrolled diabetes, long-term steroid use, cardiovascular risk, bleeding tendency, or other relevant conditions.
9) Any other patients deemed inappropriate for participation by the principal investigator or sub-investigators.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
yutakabe@keio.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
Homepage URL
yutakabe@keio.jp
Sponsor or person
Institute
Keio University
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
the Keio University School of Medicine, Ethics Committee
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2025 | Year | 09 | 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
| 2025 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067273
