Single-Port Robot-Assisted Radical Distal Gastrectomy: Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a single-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Multi-Port Robot-Assisted Radical Distal Gastrectomy: Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a multi-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 0-1.
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach — 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.
Trial sites (5)
Facility
City
Region
Status
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan
Shandong
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Beijing Tsinghua Changgung Hospital
Beijing
China
PLA Army Characteristic Medical Center
Chongqing
China
More First Affiliated Hospital of Wenzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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