Remote Versus On-Site Robotic Surgery for Hepatobiliary and Pancreatic Procedures

Summary

This study will compare remote robotic surgery with on-site robotic surgery for patients who need surgery for diseases of the liver, bile duct, gallbladder, or pancreas. Remote robotic surgery means that an experienced surgeon controls the robotic surgical system from a different location, while the patient and the operating room team are at the local hospital. On-site robotic surgery means that the surgeon controls the robotic system in the same hospital as the patient.

The main purpose of this study is to find out whether remote robotic surgery is not worse than on-site robotic surgery in terms of surgical success. Surgical success means that the planned robotic operation is completed safely, without unplanned conversion to open surgery or standard laparoscopic surgery, without major unexpected injury, and without serious problems related to the remote robotic system, network, or communication.

Eligible patients will be adults who are scheduled to undergo selected robotic hepatobiliary or pancreatic procedures, including hepatectomy, liver segmentectomy, local liver resection, cholecystectomy, pancreaticoduodenectomy, or distal pancreatectomy. Participants will be randomly assigned to either the remote robotic surgery group or the on-site robotic surgery group. The study is single-blind, which means that participants will not know which group they are assigned to, although the surgical and operating room teams will know because of the nature of the procedure.

The study will evaluate surgical success, operation time, blood loss, conversion to open surgery, complications, recovery after surgery, length of hospital stay, readmission, reoperation or other interventions, death within 30 and 90 days after surgery, and quality of recovery. For patients in the remote robotic surgery group, the study will also record the performance of the remote surgical system, including network delay, system stability, image transmission, system interruption, and the need for local surgical takeover.

A total of 168 patients are planned to be enrolled. Patients will be followed during hospitalization and after surgery to assess safety, recovery, and short-term clinical outcomes. The results of this study may help determine whether remote robotic surgery can be safely and effectively used for hepatobiliary and pancreatic surgery, especially in hospitals or regions where access to experienced surgical specialists is limited.

Conditions

• Hepatobiliary and Pancreatic Diseases

Interventions

PROCEDURE

Remote Robotic Surgery

Participants in this group will undergo remote robotic hepatobiliary or pancreatic surgery. The surgeon will control the robotic surgical system from a remote location, while the patient, local surgical team, anesthesia team, nursing team, and technical support team remain in the local operating room.

PROCEDURE

On-Site Robotic Surgery

Participants in this group will undergo on-site robotic hepatobiliary or pancreatic surgery performed by a qualified local robotic surgeon at the same hospital where the patient is treated.

Sponsors & Collaborators

• West China Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2029-06-30

Completion

2030-06-30