Robotic Surgical Procedures, Stomach Neoplasms
Conditions
Brief summary
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Interventions
DEVICESingle-Port Robotic Surgical System
An investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.
PROCEDURETraditional Laparoscopic Surgery
Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years inclusive. ECOG performance status ≤ 2. Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction. Clinical stage cT1-T3, N0-N+, M0. Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm. Candidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis. Assessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy. Radiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI). ASA physical status classification ≤ III. Adequate bone marrow, hepatic, renal, cardiac, and pulmonary function. Ability to understand and provide written informed consent. Willingness and ability to comply with the 12-month postoperative follow-up schedule.
Exclusion criteria
* Clinical stage T4 or presence of distant metastasis. Esophageal invasion exceeding 2 cm. History of previous major gastric surgery (e.g., partial or total gastrectomy). Other malignant tumors within the last 5 years. Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis). Requirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction. Pregnant or lactating women. Serious psychiatric disorders or cognitive impairment that interferes with study compliance. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II) | Within 30 days postoperatively. | The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | During the surgical procedure (Day 0). | The amount of blood lost during the surgical procedure, measured in milliliters (mL). |
| Time to First Flatus | Up to 30 days postoperatively. | The time from the end of surgery until the participant's first passage of flatus, measured in days. |
| Total Operation Time | During the surgical procedure (Day 0). | The duration from the initial skin incision to the completion of skin closure, measured in minutes. |
| Conversion Rate | During the surgical procedure (Day 0). | The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors. |
Countries
China
Contacts
CONTACTXian Shen
Outcome results
None listed