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Robotic vs Laparoscopic Gastrectomy for cT4a Gastric Cancer

NCT07331454 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal of this multicenter, randomized, phase III clinical trial is to test whether robot-assisted radical gastrectomy improves 3-year recurrence-free survival versus laparoscopy-assisted radical gastrectomy in adults aged 18-80 years with previously untreated, resectable cT4a gastric adenocarcinoma and non-bulky lymph nodes; the main questions are whether the robotic approach confers superior RFS and maintains equivalent peri-operative safety (Clavien-Dindo ≥ II complications) and better secondary oncologic outcomes, and participants will be randomized 1:1 to undergo standardized D2 resection via robotic or laparoscopic technique and followed for 5 years with scheduled recurrence, survival, and quality-of-life assessments.

Conditions

  • Gastric Cancer (GC)

Interventions

PROCEDURE

Robotic Gastrectomy

Radical gastrectomy (distal or total) performed with the da Vinci robotic system, including standardized D2 lymph-node dissection, aiming for R0 resection. All operative steps (lymph-node dissection, vessel ligation, digestive reconstruction) are completed with robotic instrumentation under 3-D high-definition vision and tremor-filtered wristed instruments.

PROCEDURE

Laparoscopic Gastrectomy

Radical gastrectomy procedure (distal or total) performed with conventional laparoscopic instruments, including the same mandatory D2 lymph-node dissection and R0 resection criteria.

Sponsors & Collaborators

  • First Affiliated Hospital of Suzhou Medical College

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331454 on ClinicalTrials.gov