Health TrialsbyHealthPanel

Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

ConditionGastric Cancer, Gastroesophageal Junction Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSouthwest Hospital, China

About this trial

This \[Study Type: Clinical Trial\] aims to \[Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer\] in \[Participant Population: patients with locally advanced gastric cancer, aged \>18 years and \<75 years\]. The primary questions it seeks to answer are:

Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare \[Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy\] to determine whether \[robotic surgery offers advantages in long-term efficacy and perioperative safety\].

Participants will:

Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group.

Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively).

Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years and < 75 years.

Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.

Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.

No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.

Disqualifiers

Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.

History of upper abdominal surgery (excluding laparoscopic cholecystectomy).

Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).

Patient underwent emergency surgery due to gastric tumor bleeding or perforation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic Gastrectomy

    Procedure/Surgery

    The intervention measures for robotic gastrectomy include: Preoperative Preparation: Comprehensive preoperative examinations, including imaging studies, laboratory tests, and tumor marker assessments, to confirm the diagnosis and staging. Surgical Procedure: Utilizing the da Vinci Surgical System, which provides a high-definition 3D view and flexible robotic arms for enhanced surgical precision. Lymphadenectomy: Systematic D2 lymph node dissection according to oncological standards to ensure thorough removal of regional lymph nodes. Gastrectomy and Reconstruction: Performing subtotal or total gastrectomy based on tumor location and extent, with intracorporeal reconstruction assisted by the robotic system. Postoperative Management: Close monitoring of vital signs, pain management, and early mobilization to facilitate recovery, along with prevention and management of postoperative complications.

  • Laparoscopic Gastrectomy

    Procedure/Surgery

    Preoperative Preparation: Confirm diagnosis and staging through imaging and laboratory tests. Surgical Procedure: Use standard laparoscopic instruments and 2D HD camera. Lymphadenectomy: Perform systematic D2 lymph node dissection. Gastrectomy and Reconstruction: Conduct subtotal or total gastrectomy and intracorporeal reconstruction. Postoperative Management: Monitor vital signs, manage pain, and promote early mobilization.

Treatment groups

740 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

3-year disease-free survival rate

Time frame
3 years

Secondary outcomes

1

Overall postoperative complication rate

Time frame
3 years
2

Intraoperative complication rate

Time frame
3 years
3

Overall postoperative complication rate of Clavien-Dindo Grade II or higher

Time frame
3 years
4

3-year OS rate

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Southwest Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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