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Not yet recruiting NCT05235932

the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

No phase Interventional Gastric Cancer Robotic Gastrectomy

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: Robotic radical total gastrectomy with D2 lymphadenectomy, Laparoscopic radical total gastrectomy with D2 lymphadenectomy.
Who it may be relevant to
Registry conditions: Gastric Cancer, Robotic Gastrectomy. Basic parameters: 18 years — 75 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, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Overview

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .

Detailed description

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.

Interventions

  • Procedure Robotic radical total gastrectomy with D2 lymphadenectomy
    Most surgical procedures are performed using the robot system.
  • Procedure Laparoscopic radical total gastrectomy with D2 lymphadenectomy
    Without the robot system, Most surgical procedures are performed using laparoscopic equipment.

Primary outcome measures

  • 3-year disease free survival rate [Time frame: 36 months]
Secondary outcome measures (9)
  • Morbidity rates [Time frame: 30 days]
  • 3-year overall survival rate [Time frame: 36 months]
  • 3-year recurrence pattern [Time frame: 36 months]
  • intraoperative morbidity rates [Time frame: 1 day]
  • overall postoperative serious morbidity rates [Time frame: 30 days]
  • Total Number of Retrieved Lymph Nodes [Time frame: 1 day]
  • postoperative recovery course [Time frame: 30 days]
  • postoperative nutritional status [Time frame: 3, 6, 9 and 12 months]
  • inflammatory immune response [Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days]

Eligibility criteria

Inclusion criteria

  • 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.

3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.

5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent

Exclusion criteria

  • Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy(except for ESD/EMR for gastric cancer )
  • Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
  • History of other malignant disease within the past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1 (forced expiratory volume in one second)<50% of predicted values

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
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT05235932 · 2022-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗