Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062618) titled 'Robotic versus Laparoscopic Liver Resection fro Liver Tumors: A Multicenter Randomized Controlled Trial' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Endoscopic Liver Surgery Study Group
Condition:
Condition - Liver tumors (benign, borderline malignant, or malignant)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Robotic liver resection
Interventions/Control_2 - laparoscopic liver resection
Eligibility:
Age-lower limit - 18
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 Size - 500
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 19 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2029 Year 10 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071672
Disclaimer: Curated by HT Syndication.