Gastric Cancer
Conditions
Keywords
robotic-assisted gastrectomy, laparoscopic-assisted gastrectomy, gastric cancer
Brief summary
The study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.
Detailed description
This is a prospective study lasting 36 months. Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability. This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.
Interventions
PROCEDURERobotic-assisted Gastrectomy(RAG)
Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.
PROCEDURELaparoscopic-assisted Gastrectomy(LAG)
Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.
Sponsors
wei bo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically proven gastric cancer(early or advanced). 2. Age:older than 18 years old,younger than 80 years old. 3. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition 4. No obvious surgical contraindications. 5. American Society of Anesthesiology (ASA) score class I, II, or III 6. Written informed consent.
Exclusion criteria
1. Severe mental disorder 2. Pregnancy 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection. 5. History of unstable angina or myocardial infarction within past six months 6. History of previous neoadjuvant chemotherapy or radiotherapy 7. History of other malignant disease within past 5 years. 8. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 9. Any accompanying surgical condition needed to be performed in the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Five-year disease free survival rate | Up to 5 years post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication (score based on the Clavien-Dindo classification system) | 30 days | Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system. |
| Mortality | 30 days | Measured as 30-day mortality rate |
| Hospitalization expenses | 30 days | the cost from admission to discharge |
| Quality of life | Up to 5 years post-operative | The validated quality of life questionnaires EORTC QLQ-30 will be filled in pre-operative \<5 days and post-operative at 6, 12, 24, 36, 48 and 60 months after surgery. |
| Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay) | 7 days | time to first ambulation,flatus,liquid diet and soft diet,post-operative stay |
| Readmissions and recurrence rate | Up to 5 years post-operative | The number of postoperative readmissions and recurrence rate. |
| Operating time | 1 day | The operating time was defined as the time from skin incision to wound closure. |
| Intraoperative situation (The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion) | 1 day | The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion |
| Five-year overall survival rate | Up to 5 years post-operative | — |
Contacts
Primary ContactWei bo, MD
Backup ContactLv xiaoye, bachelor
Outcome results
None listed