A Prospective Single-arm Study Evaluating the Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Rate of Successful Completion of Robotic Surgery Without Conversion
研究概览
简要总结
Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma is a challenging malignancy located at the anatomical transition between the esophagus and stomach. Due to its complex anatomical location and mixed biological characteristics of esophageal and gastric cancers, the optimal surgical strategy remains controversial. Current surgical approaches vary in terms of operative access, extent of resection, and lymph node dissection. Although minimally invasive laparoscopic and integrated robotic surgery have demonstrated potential advantages in improving perioperative outcomes, limitations remain when managing complex procedures involving both abdominal and mediastinal fields.
Split-type robotic surgical systems, characterized by independently movable robotic carts, provide greater flexibility in robotic arm positioning and may overcome some limitations associated with conventional integrated robotic platforms, particularly in extensive multi-quadrant procedures requiring simultaneous abdominal and mediastinal lymph node dissection. However, clinical evidence regarding the safety and effectiveness of split-type robotic surgery for Siewert type II/III GEJ cancer remains limited.
This prospective single-arm clinical study aims to evaluate the feasibility, safety, and short-term surgical outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will assess perioperative outcomes, including operative characteristics, postoperative complications, lymph node dissection quality, and short-term recovery parameters. The findings of this study are expected to provide preliminary clinical evidence regarding the application of split-type robotic technology in complex GEJ cancer surgery and support future large-scale clinical investigations.
详细描述
Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma represents a unique clinical entity located at the junction between the distal esophagus and proximal stomach. According to the Siewert classification, type II tumors are defined as tumors with their epicenter located from 1 cm above to 2 cm below the esophagogastric junction, whereas type III tumors extend from 2 cm to 5 cm below the junction. Due to their distinct anatomical characteristics and lymphatic drainage patterns, these tumors present unique challenges in surgical management.
Siewert type II tumors have a relatively increased risk of mediastinal lymph node metastasis, while Siewert type III tumors primarily involve abdominal lymphatic pathways. Consequently, significant controversy remains regarding the optimal surgical approach, including the choice between transthoracic and transabdominal approaches, esophagectomy versus gastrectomy, and the appropriate extent of lymphadenectomy. In particular, the management of Siewert type II tumors remains debated because of their overlapping features between esophageal and gastric cancers. Currently, Siewert type III tumors are generally treated according to gastric cancer principles, with total gastrectomy and D2 lymphadenectomy being widely accepted surgical strategies.
Minimally invasive surgery has increasingly been applied in GEJ cancer treatment. Previous studies have demonstrated that laparoscopic surgery may provide advantages in reducing surgical trauma and improving short-term postoperative recovery compared with open surgery. However, existing evidence is primarily derived from retrospective studies, with considerable heterogeneity and limited long-term oncological outcome data.
Robotic-assisted surgery has emerged as an advanced minimally invasive approach, offering three-dimensional visualization, enhanced instrument dexterity, motion scaling, and improved ergonomics. Small retrospective series using the da Vinci integrated robotic platform for Siewert type II/III GEJ cancer surgery have demonstrated acceptable perioperative safety and feasibility. However, conventional integrated robotic systems have limitations in complex procedures requiring extensive operative fields. Due to restricted robotic arm mobility and fixed configuration, procedures involving both thoracic and abdominal regions may require intraoperative redocking, which may interrupt surgical workflow, prolong operative time, and reduce procedural efficiency.
The split-type robotic surgical system provides an alternative robotic platform design consisting of multiple independently movable robotic carts. This configuration allows more flexible arrangement of robotic arms according to surgical requirements and may be particularly advantageous for Siewert type II/III GEJ cancer surgery, where both mediastinal and abdominal lymph node dissection may be required. Compared with integrated robotic systems, split-type robotic platforms may reduce the need for intraoperative redocking, maintain procedural continuity, decrease mechanical interference, and improve surgical efficiency during complex multi-quadrant operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 between 18 and 80 years, inclusive, regardless of sex.
- •Histologically and/or cytologically confirmed Siewert type II or type III gastroesophageal junction tumor, with clinical staging according to AJCC 8th edition TNM classification indicating suitability for curative surgical resection.
- •Adequate organ function as assessed by the investigator before surgery.
- •Provision of written informed consent and willingness to participate in the study.
- •Ability and willingness to comply with study procedures and follow-up requirements.
- •ECOG performance status of 0-
- •Absence of distant metastasis confirmed by preoperative thoracoabdominal and pelvic CT or PET-CT.
排除标准
- •Patients with body mass index (BMI) <18.5 kg/m² or BMI ≥35 kg/m².
- •Patients with severe cardiac, pulmonary, neurological, hepatic, or renal diseases that may prevent tolerance of surgery or anesthesia.
- •Patients unable to tolerate pneumoperitoneum or considered by the investigator to have extensive intra-abdominal adhesions or other conditions preventing safe establishment of pneumoperitoneum.
- •Patients with severe coagulation disorders that contraindicate minimally invasive surgery.
- •Patients with active pulmonary tuberculosis.
- •Patients with severe uncontrolled diseases, acute infections, severe physical deterioration, massive ascites, active intra-abdominal bleeding, or shock.
- •Patients with metastatic lymph nodes fused together or encasing major blood vessels, making curative resection infeasible.
- •Patients with previous abdominal/pelvic surgery, radiotherapy, or chemotherapy that may affect the feasibility of laparoscopic or robotic surgery.
- •Pregnant or breastfeeding women.
- •Patients currently participating in other clinical trials involving investigational drugs or medical devices.
- •Patients considered unsuitable for this study by the investigator.
研究组 & 干预措施
Carina Robotic Surgery Group
Patients with Siewert type II/III gastroesophageal junction adenocarcinoma who undergo radical surgical resection assisted by the Carina modular surgical robotic system. All participants will receive the same robotic surgical intervention, and perioperative safety, surgical outcomes, pathological outcomes, and short-term postoperative recovery will be evaluated prospectively.
干预措施: Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer (Procedure)
结局指标
主要结局
Rate of Successful Completion of Robotic Surgery Without Conversion
时间窗: Intraoperatively
The proportion of patients who successfully complete radical resection using the Carina modular robotic surgical system without conversion to conventional laparoscopy or open surgery. Conversion includes unplanned transition to another surgical approach due to technical difficulties, intraoperative complications, or inability to complete the planned robotic procedure.
Incidence of Perioperative Complications (Clavien-Dindo Classification)
时间窗: Within 30 days after surgery
The incidence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system. Complications include surgical and medical adverse events occurring during the perioperative period.
次要结局
- Achievement Rate of D2 Lymphadenectomy(Perioperative/Periprocedural)
- Number and Metastatic Rate of Lymph Nodes in the Lower Mediastinal and Suprapancreatic Regions(Within 14 days after surgery (pathological assessment))
- Postoperative Pathological Stage (pTNM Classification)(Within 14 days after surgery)
- R0 Resection Rate(Within 14 days after surgery)
- Proximal and Distal Resection Margin Distance(Within 14 days after surgery)
- Incidence of Specific Postoperative Complications(Within 30 days after surgery)
- Estimated Intraoperative Blood Loss(During the index operation)
- Device- and Instrument-related Adverse Events(From surgery initiation to 30 days after surgery)
- Type of Gastrointestinal Reconstruction(During surgery)
- 30-day Postoperative Mortality(Within 30 days after surgery)
- 30-day Hospital Readmission Rate(Within 30 days after surgery)
- ICU Admission Rate and Duration of ICU Stay(From surgery until hospital discharge)
- Postoperative Hospital Stay(From postoperative day 1 until hospital discharge)
- System Preparation Time(Perioperative/Periprocedural)
- Robotic Arm Docking Time(During surgery preparation)
- Robot-assisted Operative Time(During surgery)
- Total Operative Time(During surgery)
- Redocking Events and Duration(Perioperative/Periprocedural)
- Surgical Interruption Events and Duration(Perioperative/Periprocedural)
- Time to First Ambulation(From completion of surgery until first postoperative ambulation)
- Time to First Postoperative Flatus(From completion of surgery until first postoperative flatus)
- Time to Initiation of Liquid Diet(From completion of surgery until initiation of oral liquid intake)
- Postoperative Pain Score(Postoperative days 1-7)
- Surgeon Physiological and Mental Workload Assessment(During surgery)
- Surgeon Physical Workload Assessed by the Local Experienced Discomfort Scale(Immediately after surgery)
- Surgeon Mental Workload Assessed by the Subjective Mental Effort Questionnaire(Immediately after surgery)
研究者
Quan Wang
Professor
The First Hospital of Jilin University