RecruitingNot ApplicableNCT07586384

Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial

A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Enrollment

90 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

Stomach Neoplasms Robotic Surgical Procedures

Summary

To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria12

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 Criteria9

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.

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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.