Safety and Efficacy of Remote Versus On-Site Robotic Surgery in Hepatobiliary and Pancreatic Procedures: An International, Multicenter, Prospective, Randomized, Single-Blind, Non-Inferiority Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Surgical Success Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Surgical Success Rate
时间窗: From surgery to hospital discharge, assessed up to 30 days after surgery.
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.
次要结局
未报告次要终点