Gastric Cancer, Robotic Gastrectomy
Conditions
Keywords
Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy
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.
Interventions
PROCEDURETotal Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
PROCEDURERobotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age from over 18 to under 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition 4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results. 5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale 6. American Society of Anesthesiology (ASA) class I to III 7. Written informed consent
Exclusion criteria
1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer) 5. Gastric multiple primary carcinoma 6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging 7. History of other malignant disease within the past 5 years 8. History of previous neoadjuvant chemotherapy or radiotherapy 9. History of unstable angina or myocardial infarction within the past 6 months 10. History of cerebrovascular accident within the past 6 months 11. History of continuous systematic administration of corticosteroids within 1 month 12. Requirement of simultaneous surgery for other disease 13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 14. Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity rates | 30 days | This is for the early postoperative complication, which defined as the event observed within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival rate | 36 months | 3-year overall survival rate |
| 3-year recurrence pattern | 36 months | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. |
| intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
| overall postoperative serious morbidity rates | 30 days | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher |
| 3-year disease free survival rate | 36 months | 3-year disease free survival rate |
| postoperative recovery course | 30 days | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. |
| postoperative nutritional status | 3, 6, 9 and 12 months | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. |
| inflammatory immune response | Preoperative 3 days and postoperative 1, 3, and 5 days | The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response |
| Time of digestive tract reconstruction | 1 day | From the beginning to the end of digestive tract reconstruction |
| Total Number of Retrieved Lymph Nodes | 1 day | Total Number of Retrieved Lymph Nodes |
Countries
China
Contacts
Primary ContactChang-ming Huang, MD
Backup ContactQi-yue Chen, PhD
Outcome results
None listed