A Study About Remote and Local Liver Surgery

NCT07524699 | Not Yet Recruiting DMC

• 1 other identifier: Remote Liver Surgery-1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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 surgical success rate in the field of remote liver surgery compared to local surgery. It will also learn about the safety of remote liver surgery. The main questions are: Does remote liver surgery not lower the probability of conversing to open or laparoscopic or local liver surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local liver surgery to see if remote liver surgery doesn't lower the surgical conversion rate. Participants will: Undergo remote or local 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.

Conditions

Liver Diseases

Keywords

Remote Surgery; Liver Surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Surgical success rate

  The number of subjects who successfully completed remote surgical treatment using the experimental equipment, as a proportion of the total number of subjects. The definition of a successful surgery: (a) The surgical process was completed according to the original plan; (b) There was no conversion of surgical methods, such as remote-local, remote-laparoscopic/open; (c) There was no delay due to failure of the surgical system. Whether each case was successful should be confirmed by the medical team after the surgery based on the pre-set criteria for judgment.

  6 weeks

• The incidence rate of complications of grade 3 and above

  The number of subjects who experienced complications of grade 3 or above, as a proportion of the total number of subjects. Definition: The incidence rate of complications that are definitely or possibly related to the device and meet the Clavien-Dindo classification system criteria of grade 3 or above from the first incision to 6 weeks after the surgery. The complication grade is from 1 to 5. The higher grade means a worse result. Grade 1: Any deviation from the normal postoperative course without need for pharmacological treatment or surgical, endoscopic, or radiological interventions. Grade 2: Complications requiring pharmacological treatment other than those allowed in Grade I, including blood transfusions and total parenteral nutrition. Grade 3: Complications requiring surgical, endoscopic, or radiological intervention. Grade 4: Life-threatening complications requiring intermediate care (IC) or intensive care unit (ICU) management. Grade 5: Death of a patient.

  6 weeks

Secondary Outcomes (16)

• Overall complication rate

  6 weeks

• Operation Time

  During surgery

• Console Time

  During surgery

• Blood loss

  During surgery

• Positive Margin rate

  In one week after surgery

Study Arms (2)

Local Surgery

ACTIVE COMPARATOR

The patients in this arm (group) will undergo local liver surgery according to random allocation.

Device: Local Liver Surgery

Remote Surgery

EXPERIMENTAL

The patients in this arm (group) will undergo remote liver surgery according to random allocation.

Device: Remote Liver Surgery

Interventions

Remote Liver Surgery DEVICE

The patients in this arm will undergo remote liver surgery.

Remote Surgery

Local Liver Surgery DEVICE

The patients in this arm will undergo local liver surgery.

Local Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18-75 years old (inclusive), gender not restricted;
• BMI: 18-30 Kg/m2;
• Relevant indications for liver surgery;
• Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;
• Willing to cooperate and complete follow-up and related subsequent examinations;
• Voluntary to sign the informed consent form;
• Indocyanine green 15-minute retention rate (ICG-R15) \< 15%, and liver function Child-Pugh grade is A.

You may not qualify if:

• Patients with severe circulatory system diseases who cannot tolerate surgery;
• Pregnant or lactating women;
• Patients with a history of epilepsy or mental illness;
• Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;
• Patients who cannot understand the research requirements or who cannot complete the research follow-up;
• Patients considered unsuitable to participate in this trial by the researchers.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Tongji Hospital: lead
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Xinqiao Hospital, Amry Medical University: collaborator
• Zhujiang Hospital: collaborator
• First Affiliated Hospital of Chengdu Medical College: collaborator
• The First Medical Center of Chinese PLA General Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Wuhan TongJi Hospital: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Peng Zhu, Medicine Doctor

CONTACT

+86-13907170712; zhupeng@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Surgery

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 13, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)