Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
- Conditions
- Robotic SurgeryStomach Neoplasm
- Interventions
- Procedure: Robotic Assisted Total GastrectomyProcedure: Laparoscopic Assisted Total Gastrectomy
- Registration Number
- NCT03524300
- Lead Sponsor
- Fujian Medical University
- Brief Summary
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
- Detailed Description
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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 cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
- cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Multiple primary cancer
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )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
- FEV1<50% of the predicted values
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic Assisted Total Gastrectomy Robotic Assisted Total Gastrectomy Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. Laparoscopic Assisted Total Gastrectomy Laparoscopic Assisted Total Gastrectomy Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months the rate of 3-year disease free survival
- Secondary Outcome Measures
Name Time Method Time to first flatus 30 days Time to first flatus in days is used to assess the postoperative recovery course.
3-year overall survival rate 36 months the rate of 3-year overall survival rate
operation time 1 day operation time
3-year recurrence pattern 36 months the pattern of recurrence in 3 years
Time to first liquid diet 30 days Time to first liquid diet in days is used to assess the postoperative recovery course
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.
The variation of weight 3, 6, 9 and 12 months The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
overall postoperative morbidity rates 30 days Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time to first ambulation 30 days Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first soft diet 30 days Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay 30 days Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
The variation of white blood cell count Preoperative 3 days and postoperative 1, 3, and 5 days The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory response.
Hospitalization expenses 30 days The cost from admission to discharge
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China