Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG
- Conditions
- Esophagogastric Junction Adenocarcinoma
- Interventions
- Procedure: Laparoscopic Assisted AEG Radical GastrectomyProcedure: Robotic Assisted AEG Radical Gastrectomy
- Registration Number
- NCT04153058
- Lead Sponsor
- Fujian Medical University
- Brief Summary
The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）
- Detailed Description
In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. 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 radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 300
- 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
- cT2-4a(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 total gastrectomy with D2+No.19+No.20 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
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- 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 Laparoscopic Assisted AEG Radical Gastrectomy Laparoscopic Assisted AEG Radical Gastrectomy Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma Robotic Assisted AEG Radical Gastrectomy Robotic Assisted AEG Radical Gastrectomy Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months 3-year disease free survival rate
- Secondary Outcome Measures
Name Time Method 3-year recurrence pattern 36 months 3-year recurrence pattern
Time to first ambulation 30 days Time to first ambulation is used to access the postoperative recovery course.
The amount of abdominal drainageare 30 days The amount of abdominal drainageare is used to access the postoperative recovery course.
intraoperative morbidity rates 1 day intraoperative morbidity rates
overall postoperative serious morbidity rates 30 days overall postoperative serious morbidity rates
Duration of hospital stay 30 days Duration of hospital stay is used to access the postoperative recovery course.
3-year overall survival rate 36 months 3-year overall survival rate
overall postoperative morbidity rates 30 days overall postoperative morbidity rates
Time to soft diet 30 days Time to soft diet is used to access the postoperative recovery course.
number of retrieved lymph nodes 14 days number of retrieved lymph nodes
Time to first liquid diet 30 days Time to first liquid diet is used to access the postoperative recovery course.
Time to first flatus 30 days Time to first flatus is used to access the postoperative recovery course.
Hospitalization costs 30 days Hospitalization costs
postoperative nutritional status 3, 6, 9 and 12 months Weight and height will be combined to report BMI in kg/m\^2. The variation of BMI in kg/m\^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China