A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

NCT ID: NCT06353672

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2026-12-31

Brief Summary

The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.

This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR.

Conditions

Liver Diseases; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic liver resection

Group Type: EXPERIMENTAL

Robotic liver resection

Intervention Type: DEVICE

Liver resection using Da Vinci robotic system

Interventions

Robotic liver resection

Liver resection using Da Vinci robotic system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patients were diagnosed with a liver tumor.
• The patients underwent robotic liver resection.

Exclusion Criteria

• The patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tingbo Liang, MD,PHD

Role: primary

liangtingbo@zju.edu.cn

086-571-87236688

Other Identifiers

RLR-01

Identifier Type: -

Identifier Source: org_study_id