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Not yet recruiting NCT04795063

Total Robotic Versus Robotic Assisted Distal Gastrectomy for 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: Total Robotic Distal Gastrectomy, Robotic-Assisted Distal Gastrectomy.
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

Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Overview

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, 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 total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Interventions

  • Procedure Total Robotic Distal Gastrectomy
    All the surgical procedures are performed using the robot system.
  • Procedure Robotic-Assisted Distal Gastrectomy
    After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

Primary outcome measures

  • Morbidity rates [Time frame: 30 days]
Secondary outcome measures (10)
  • 3-year disease free survival rate [Time frame: 36 months]
  • 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]
  • Time of digestive tract reconstruction [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • American Society of Anesthesiology (ASA) class I to III
  • Written informed consent

Exclusion criteria

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
  • Gastric multiple primary carcinoma
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Forced expiratory volume in 1 second (FEV1)<50% of the 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: NCT04795063 · FUGES-022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗