Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-Port Robotic Surgical System, Traditional Laparoscopic Surgery.
- Who it may be relevant to
- Registry conditions: Stomach Neoplasms, Robotic Surgical Procedures. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
Overview
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Interventions
- Device Single-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. - Procedure Traditional 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.
Primary outcome measures
- Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II) [Time frame: Within 30 days postoperatively.]
Secondary outcome measures (4)
- Estimated Blood Loss [Time frame: During the surgical procedure (Day 0).]
- Time to First Flatus [Time frame: Up to 30 days postoperatively.]
- Total Operation Time [Time frame: During the surgical procedure (Day 0).]
- Conversion Rate [Time frame: During the surgical procedure (Day 0).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
Identifiers
NCT: NCT07586384 · KY2025-143 · ChiCTR2500109905