Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Fujian Medical University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Morbidity rates
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Chang-Ming Huang, Prof.
Professor
Fujian Medical University
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
Outcomes
Primary Outcomes
Morbidity rates
Time Frame: 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Secondary Outcomes
- 3-year disease free survival rate(36 months)
- 3-year overall survival rate(36 months)
- 3-year recurrence pattern(36 months)
- intraoperative morbidity rates(1 day)
- overall postoperative serious morbidity rates(30 days)
- Total Number of Retrieved Lymph Nodes(1 day)
- postoperative recovery course(30 days)
- postoperative nutritional status(3, 6, 9 and 12 months)
- inflammatory immune response(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Time of digestive tract reconstruction(1 day)