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

NCT07716423 | Not Yet Recruiting DMC

• 1 other identifier: TELEHPB-001
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Remote Robotic Surgery; Telerobotic Surgery; On-Site Robotic Surgery; Hepatobiliary Surgery; Pancreatic Surgery

Outcome Measures

Primary Outcomes (1)

• Surgical Success Rate

  The percentage of participants who achieve surgical success. Surgical success is defined as completion of the planned robotic hepatobiliary or pancreatic procedure without unplanned conversion to open surgery or conventional laparoscopic surgery, without major unexpected injury such as major vascular injury, major bile duct injury, unexpected main pancreatic duct injury, or uncontrollable bleeding, and without serious interruption or failure related to the remote robotic system, network, image transmission, communication, or device performance.

  From surgery to hospital discharge, assessed up to 30 days after surgery.

Study Arms (2)

Remote Robotic Surgery Group

EXPERIMENTAL

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: Remote Robotic Surgery

On-Site Robotic Surgery Group

ACTIVE COMPARATOR

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.

Procedure: On-Site Robotic Surgery

Interventions

On-Site Robotic Surgery PROCEDURE

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.

On-Site Robotic Surgery Group

Remote Robotic Surgery PROCEDURE

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.

Remote Robotic Surgery Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years, regardless of sex.
• Scheduled to undergo robot-assisted hepatobiliary or pancreatic surgery, limited to hemihepatectomy, liver segmentectomy, local liver resection, cholecystectomy, pancreaticoduodenectomy, or distal pancreatectomy.
• Considered to have an indication for surgery and to be suitable for robotic surgery based on preoperative assessment.
• No definite contraindication to robotic surgery, laparoscopic surgery, pneumoperitoneum, or general anesthesia.
• American Society of Anesthesiologists (ASA) physical status class I to III.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
• Expected survival of at least 3 months.
• Adequate major organ function, with laboratory test results within 7 days before enrollment meeting the following criteria: white blood cell count at least 2.5 x 10\^9/L, absolute neutrophil count at least 1.5 x 10\^9/L, platelet count at least 75 x 10\^9/L, hemoglobin at least 90 g/L, international normalized ratio no more than 1.5 x upper limit of normal, and serum creatinine no more than 1.5 x upper limit of normal.
• For patients undergoing liver surgery, Child-Pugh class A liver function or Child-Pugh class B liver function considered tolerable for surgery, with adequate liver reserve and adequate predicted future liver remnant volume.
• For patients undergoing pancreatic surgery, imaging assessment showing resectability by robotic surgery without the need for complex vascular reconstruction.
• Willing and able to complete perioperative observation and postoperative follow-up according to the study protocol.
• Voluntarily agrees to participate in the study and provides written informed consent.

You may not qualify if:

• Need for combined vascular reconstruction.
• Need for two or more major hepatobiliary or pancreatic procedures at the same time, or need for major resection of other organs.
• Unable to complete full preoperative assessment, randomization, or remote robotic system preparation.
• Considered clearly unsuitable for robotic surgery before the operation.
• Preoperative assessment indicating a high probability of conversion to open surgery, or difficulty safely completing the planned procedure using a robotic platform.
• Uncorrectable severe coagulation disorder or active bleeding tendency.
• Severe dysfunction of the heart, lung, liver, kidney, brain, or other major organs that makes the patient unable to tolerate general anesthesia, pneumoperitoneum, or the planned surgery.
• For patients undergoing liver surgery, inadequate liver reserve or inadequate predicted future liver remnant volume for safe surgery.
• Uncontrolled severe infection, sepsis, severe malnutrition, or other conditions that significantly increase perioperative risk.
• Pregnant or breastfeeding women.
• Severe psychiatric, cognitive, or communication disorder that prevents cooperation with the study or follow-up.
• Major compliance concerns as judged by the investigator.
• Currently participating in another interventional clinical study that may affect endpoint assessment in this study.
• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Yunshi Cai

CONTACT

+86 18323424374; caiyunshi@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share