A Study About Remote and Local Liver Surgery

NCT07524699 · tracked via the Priya Life Science China tracker

Sponsor

Tongji Hospital

Phase

Not applicable

Started

2026-05-16

Last updated

2026-05-18

Condition(s) studied

Liver Diseases

Investigational drug(s) / intervention(s)

Remote Liver SurgeryLocal Liver Surgery

Remote Liver Surgery: The patients in this arm will undergo remote liver surgery.

Local Liver Surgery: The patients in this arm will undergo local liver surgery.

Study summary

The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery.

The main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery.

Participants will:

Undergo remote or local robotic liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age range: 18-75 years old (inclusive), gender not restricted; 2. BMI: 18-30 Kg/m2; 3. Relevant indications for liver surgery; 4. Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6; 5. Willing to cooperate and complete follow-up and related subsequent examinations; 6. Voluntary to sign the informed consent form; 7. Indocyanine green 15-minute retention rate (ICG-R15) \< 15%, and liver function Child-Pugh grade is A. Exclusion Criteria: 1. Patients with severe circulatory system diseases who cannot tolerate surgery; 2. Pregnant or lactating women; 3. Patients with a history of epilepsy or mental illness; 4. Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction; 5. Patients who cannot understand the research requirements or who cannot complete the research follow-up; 6. Patients considered unsuitable to participate in this trial by the researchers.

Primary outcome measure(s)

Textbook outcome in liver surgery — 6 weeks
The textbook outcome in liver surgery is defined as the absence of intraoperative incidents of grade 2 or higher (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery),30 severe complications (Clavien-Dindo grade III or higher), postoperative reintervention (ie, surgical, endoscopic, or radiologic), readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin (ie, 1 mm or more tumor-free margin).

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524699 on ClinicalTrials.gov ↗ ← All trials in China