Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

Conditions
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Esophagogastric Junction Adenocarcinoma

Intervention / Treatment
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* Procedure: Robotic Assisted AEG Radical Gastrectomy
* Procedure: Laparoscopic Assisted AEG Radical Gastrectomy


Participation Criteria
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Eligibility Criteria
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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 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Assisted AEG Radical Gastrectomy<br>Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma | Procedure: Robotic Assisted AEG Radical Gastrectomy<br>* Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma<br>|
| Active Comparator: Laparoscopic Assisted AEG Radical Gastrectomy<br>Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma | Procedure: Laparoscopic Assisted AEG Radical Gastrectomy<br>* Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| 3-year recurrence pattern | 3-year recurrence pattern | 36 months | 
| overall postoperative morbidity rates | overall postoperative morbidity rates | 30 days | 
| intraoperative morbidity rates | intraoperative morbidity rates | 1 day | 
| overall postoperative serious morbidity rates | overall postoperative serious morbidity rates | 30 days | 
| number of retrieved lymph nodes | number of retrieved lymph nodes | 14 days | 
| Time to first ambulation | Time to first ambulation is used to access the postoperative recovery course. | 30 days | 
| Time to first flatus | Time to first flatus is used to access the postoperative recovery course. | 30 days | 
| Time to first liquid diet | Time to first liquid diet is used to access the postoperative recovery course. | 30 days | 
| Time to soft diet | Time to soft diet is used to access the postoperative recovery course. | 30 days | 
| Duration of hospital stay | Duration of hospital stay is used to access the postoperative recovery course. | 30 days | 
| The amount of abdominal drainageare | The amount of abdominal drainageare is used to access the postoperative recovery course. | 30 days | 
| postoperative nutritional status | 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. | 3, 6, 9 and 12 months | 
| Hospitalization costs | Hospitalization costs | 30 days |