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

Overview

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.

Remote robotic surgery is an emerging surgical approach that combines robotic surgical systems, high-speed network communication, digital medical platforms, and cross-regional surgical collaboration. This approach may allow experienced surgeons to perform or participate in complex operations for patients located in different hospitals, regions, or countries. It has the potential to improve access to high-quality surgical care, especially in areas where experienced hepatobiliary and pancreatic surgeons are not readily available. Hepatobiliary and pancreatic surgery is technically demanding because of the complex anatomy of the liver, bile duct, gallbladder, pancreas, major blood vessels, and digestive tract. Procedures such as liver resection, pancreaticoduodenectomy, and distal pancreatectomy require precise dissection, careful bleeding control, safe reconstruction, and close cooperation between the surgeon, local operating room team, anesthesia team, nursing team, and technical support team. For this reason, the safety and effectiveness of remote robotic surgery in this field need to be evaluated in a structured clinical trial. This is an investigator-initiated, international, multicenter, prospective, randomized, single-blind, parallel-group, non-inferiority controlled trial. The study will compare remote robotic surgery with on-site robotic surgery in patients undergoing selected hepatobiliary and pancreatic procedures. Eligible participants will be randomly assigned in a 1:1 ratio to either the remote robotic surgery group or the on-site robotic surgery group through a central randomization system. Stratified block randomization will be used to reduce imbalance among study centers and procedure types. Participants in the remote robotic surgery group will undergo robotic surgery performed by an experienced surgeon using a remote robotic control system. The patient, robotic patient-side cart, local surgical team, anesthesia team, nursing team, and technical support team will remain in the local operating room. A qualified local surgical team will be available to assist the procedure and to take over the operation if needed for patient safety. Participants in the on-site robotic surgery group will undergo standard robotic surgery performed by a qualified local robotic surgeon at the same hospital where the patient is treated. Both groups will follow standardized surgical procedures and perioperative management protocols as much as possible, including preoperative assessment, anesthesia, antibiotic prophylaxis, thrombosis prevention, postoperative pain control, enhanced recovery care, laboratory and imaging follow-up, drainage management, complication management, and discharge criteria. The study will include adult patients who are scheduled to undergo one of the following robotic hepatobiliary or pancreatic procedures: hemihepatectomy, liver segmentectomy, local liver resection, cholecystectomy, pancreaticoduodenectomy, or distal pancreatectomy. Patients must be considered suitable for robotic surgery after preoperative assessment. Patients who require complex vascular reconstruction, combined major operations, emergency surgery, or who are considered unsuitable for safe robotic surgery will not be enrolled. The primary endpoint is 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. In the remote robotic surgery group, cases that require unplanned local takeover of the main surgical procedure because of network, system, or device problems will be considered unsuccessful for the primary endpoint. Final endpoint assessment may be based on surgical records, anesthesia records, intraoperative video, remote system logs, local takeover records, adverse event records, and review by an independent endpoint adjudication committee when needed. Secondary endpoints will include intraoperative safety, operative time, robotic console time, anesthesia time, blood loss, transfusion, unplanned conversion, local takeover, system interruption, intensive care unit admission, postoperative recovery, time to ambulation, time to first oral intake, time to first flatus or bowel movement, drainage duration, postoperative length of stay, total hospital stay, hospital costs, readmission, reintervention, reoperation, 30-day mortality, 90-day mortality, and postoperative quality of recovery. Quality of recovery will be assessed using the QoR-15 scale. Physical recovery may also be assessed using functional tests such as the 30-second chair stand test. Procedure-specific outcomes will also be evaluated. For liver surgery, these may include completion of the planned resection, liver inflow occlusion method and duration, liver transection-related outcomes, R0 resection rate for malignant tumors, bile leakage, post-hepatectomy liver failure, postoperative bleeding, and dynamic changes in liver function tests. For cholecystectomy, outcomes may include achievement of the critical view of safety, gallbladder rupture, bile duct injury, unplanned drainage, unplanned common bile duct exploration, and conversion. For pancreatic surgery, outcomes may include completion of the planned pancreatic resection, reconstruction or pancreatic stump management, postoperative pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, R0 resection rate for malignant tumors, lymph node retrieval, and related postoperative complications. For the remote robotic surgery group, technical performance of the remote surgical system will be recorded, including network latency, connection stability, image quality, communication quality, packet loss or frame loss, system alarms, device malfunction, interruption time, and any need for local surgical takeover. The workload of the remote surgeon, local surgeon, assistant, scrub nurse, anesthesia team, and technical support team will be assessed using the NASA-TLX scale after surgery. The planned sample size is 168 participants, with 84 participants in the remote robotic surgery group and 84 participants in the on-site robotic surgery group. The sample size is based on a non-inferiority design using surgical success as the primary endpoint. The expected surgical success rate is 95% in both groups, with a non-inferiority margin of 10%, a one-sided alpha level of 0.025, and 80% statistical power, while allowing for potential dropout, withdrawal, major protocol deviation, preoperative cancellation, or invalid cases. All participants will be followed during hospitalization and after surgery, with key postoperative assessments planned up to 90 days after the operation. Adverse events and serious adverse events will be recorded and managed according to the study protocol and local clinical practice. The study will be conducted after ethics approval at participating centers, and written informed consent will be obtained before enrollment. The results of this trial are expected to provide clinical evidence on whether remote robotic surgery is a safe, effective, and scalable approach for selected hepatobiliary and pancreatic procedures.