NCT07828899尚未招募不适用
Safety and Efficacy Evaluation of Single-Port Versus Multi-Port Robotic-Assisted Radical Distal Gastrectomy for Gastric Cancer: a Multicenter, Prospective, Open-Label, Randomized Controlled Trial
First Affiliated Hospital of Wenzhou Medical University5 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 5
- 主要终点
- Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach
研究概览
简要总结
This multicenter randomized non-inferiority trial evaluates single-port versus multi-port robotic-assisted radical distal gastrectomy in patients with gastric cancer. A prespecified prospective substudy will assess early postoperative pain, abdominal wall trauma, and early recovery between the two surgical approaches.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years, irrespective of sex.
- •Histologically confirmed primary gastric adenocarcinoma based on endoscopic biopsy.
- •The primary tumor is located in the middle or distal third of the stomach, or at another site considered amenable to radical distal gastrectomy. Preoperative evaluation indicates that robot-assisted radical distal gastrectomy is technically feasible and that an R0 resection is anticipated. Patients who have received standard neoadjuvant therapy may also be eligible if reassessment confirms fulfillment of the above surgical criteria.
- •Clinical stage cT1-3N0-1M0 according to the 8th edition of the AJCC TNM staging system for gastric cancer, as assessed by gastroscopy and contrast-enhanced computed tomography of the chest, abdomen, and pelvis, with endoscopic ultrasonography, abdominal magnetic resonance imaging, or diagnostic laparoscopy performed when clinically indicated. Preoperative assessment should indicate that R0 resection can be achieved by distal gastrectomy, with no evidence of adjacent organ invasion or distant metastasis.
- •No history of other malignancies within the preceding 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with a similarly negligible risk of recurrence.
- •American Society of Anesthesiologists (ASA) physical status class I-III.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-
- •Adequate major organ function, with preoperative assessment confirming fitness for general anesthesia and robot-assisted radical distal gastrectomy.
- •Subjects voluntarily participate in the study, fully understand the trial protocol and provide written informed consent.
排除标准
- •Body mass index (BMI) >35 kg/m².
- •Previous gastrectomy, or a history of major upper abdominal surgery considered likely to substantially compromise the feasibility or safety of robot-assisted distal gastrectomy, such as complex hepatobiliary-pancreatic surgery or surgery involving the esophagogastric junction. Previous uncomplicated laparoscopic cholecystectomy, appendectomy, or similar procedures are not, in principle, considered exclusionary.
- •Tumor-related acute obstruction, active major hemorrhage, or perforation requiring emergency surgery.
- •Preoperative confirmation of synchronous multiple gastric cancers or remnant gastric cancer, or the presence or history within the preceding 5 years of another active malignancy that may interfere with study treatment or assessment of study endpoints.
- •Preoperative assessment indicating that radical distal gastrectomy is oncologically or technically inappropriate, including anticipated requirement for total gastrectomy, proximal gastrectomy, combined esophagectomy, or any other procedure other than distal gastrectomy.
- •Preoperative evaluation or diagnostic laparoscopy demonstrating definite invasion of adjacent organs requiring en bloc multivisceral resection; distant metastasis, including peritoneal, hepatic, pulmonary, osseous, or distant lymph-node metastasis; or positive peritoneal lavage cytology.
- •Standard preoperative evaluation indicating that the patient is not currently an appropriate candidate for upfront radical distal gastrectomy and requires initiation or continuation of neoadjuvant therapy or other antineoplastic treatment.
- •Concomitant disease requiring an additional surgical procedure at the time of radical gastrectomy that may substantially affect operative duration, perioperative safety, postoperative recovery, or assessment of the primary endpoint.
- •Pregnancy or lactation, or planned pregnancy during the study period.
- •Severe cardiac, pulmonary, hepatic, or renal dysfunction; severe coagulation abnormalities; uncontrolled infection; or any other medical condition considered to preclude safe administration of general anesthesia or surgical treatment.
- •Inability to provide valid informed consent because of cognitive impairment, psychiatric or mental status abnormalities, or other reasons, or inability to comply with protocol-specified treatment and follow-up procedures.
- •Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the study.
研究组 & 干预措施
Single-Port Robotic Gastrectomy Group
Experimental
Participants randomized to this group will undergo single-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
干预措施: Single-Port Robot-Assisted Radical Distal Gastrectomy (Procedure)
Multi-Port Robotic Gastrectomy Group
Active Comparator
Participants randomized to this group will undergo conventional multi-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
干预措施: Multi-Port Robot-Assisted Radical Distal Gastrectomy (Procedure)
结局指标
主要结局
Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach
时间窗: At the end of surgery
Technical success is defined as completion of the protocol-specified gastrectomy, lymph node dissection, and gastrointestinal reconstruction using the robotic surgical approach assigned at randomization. In the single-port group, technical success requires completion using the single-port robotic system without conversion to multi-port robotic surgery, conventional laparoscopic surgery, or open surgery, and without any unplanned additional port beyond those permitted by the protocol. In the multi-port group, technical success requires completion using the multi-port robotic system without conversion to conventional laparoscopic surgery or open surgery. Failure to complete the assigned robotic procedure because of participant-related, operative, or device-related reasons will be classified as technical failure. The prespecified noninferiority margin is -10 percentage points.
次要结局
- Robotic Docking Time(Intraoperative)
- Total Operative Time(Intraoperative)
- Robotic Console Time(Intraoperative)
- Intraoperative Blood Loss(Intraoperative)
- Percentage of Participants With Intraoperative Complications(Intraoperative)
- Percentage of Participants With R0 Resection(At completion of postoperative pathological assessment, within 30 days after surgery)
- Number of Lymph Nodes Retrieved(At completion of postoperative pathological assessment, within 30 days after surgery)
- Number of Metastatic Lymph Nodes(At completion of postoperative pathological assessment, within 30 days after surgery)
- Overall postoperative complications(From the end of surgery through 30 days after surgery)
- Percentage of Participants With Clavien-Dindo Grade III or Higher Postoperative Complications(From the end of surgery through 30 days after surgery)
- Specific surgery-related complications(From the end of surgery through 30 days after surgery)
- Percentage of Participants With Unplanned Reoperation Within 30 Days After Surgery(Within 30 days after surgery)
- Percentage of Participants With Unplanned Readmission Within 30 Days After Surgery(Within 30 days after surgery)
- Percentage of Participants Who Die Within 30 Days After Surgery(Within 30 days after surgery)
- Pain and Early Recovery Substudy: Estimated Marginal Mean Resting VAS Pain Score Across Postoperative Days 1-3(Postoperative Days 1 through 3)
- Pain and Early Recovery Substudy: Resting VAS Pain Score at 6 Hours After Surgery(6 hours after surgery)
- Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 1(Postoperative Day 1)
- Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 2(Postoperative Day 2)
- Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 3(Postoperative Day 3)
- Pain and Early Recovery Substudy: Percentage of Participants Requiring Rescue Analgesia(From the end of surgery through postoperative Day 3)
- Pain and Early Recovery Substudy: Cumulative Postoperative Opioid Consumption in Morphine Milligram Equivalents(From the end of surgery through postoperative Day 3)
- Total Abdominal Wall Incision Length(At the end of surgery)
- Maximum Length of a Single Abdominal Wall Incision(At the end of surgery)
- Time to First Postoperative Flatus(Up to 30 days after surgery)
- Time to First Postoperative Defecation(Up to 30 days after surgery)
- Time to First Postoperative Ambulation(Up to 30 days after surgery)
- Time to First Postoperative Oral Intake(Up to 30 days after surgery)
- Time to Meeting Discharge Criteria(Up to 30 days after surgery)
研究者
研究点 (5)
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