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Robotic vs Laparoscopic Gastrectomy for cT4a Gastric Cancer

ConditionGastric Cancer (GC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ANC ≥ 1.2 × 10⁹/L, platelet ≥ 100 × 10⁹/L, Hb > 8 g/dL (no transfusion/G-CSF within 14 days)

ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN (or isolated indirect hyperbilirubinaemia)

Serum creatinine ≤ 1.5 × ULN and calculated creatinine clearance ≥ 60 mL/min

INR or PT ≤ 1.5 × ULN (therapeutic low-dose anticoagulation allowed)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic Gastrectomy

    Procedure/Surgery

    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.

  • Laparoscopic Gastrectomy

    Procedure/Surgery

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

Treatment groups

335 Participants
are divided into 2 treatment groups
Group A: Robotic GastrectomyExperimental treatment 1 intervention
Group B: Laparoscopic GastrectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

RFS

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

First Affiliated Hospital of Suzhou Medical College

Collaborator

The Affiliated Hospital of Xuzhou Medical University

Collaborator

The Affiliated Jiangning Hospital of Nanjing Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: