Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Conditions
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Gastric Cancer, Robotic Gastrectomy

Intervention / Treatment
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* Procedure: Total Robotic Distal Gastrectomy
* Procedure: Robotic-Assisted Distal 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 cT1-4a (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 distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale American Society of Anesthesiology (ASA) 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 Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) 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 Forced expiratory volume in 1 second (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: Total Robotic Distal Gastrectomy<br>After exploration and randomization, patients received total robotic distal gastrectomy | Procedure: Total Robotic Distal Gastrectomy<br>* All the surgical procedures are performed using the robot system.<br>|
| Active Comparator: Robotic-Assisted Distal Gastrectomy<br>After exploration and randomization, patients received robotic-assisted distal gastrectomy. | Procedure: Robotic-Assisted Distal Gastrectomy<br>* After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rates | This is for the early postoperative complication, which defined as the event observed within 30 days after surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months | 
| intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| overall postoperative serious morbidity rates | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher | 30 days | 
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 1 day | 
| postoperative recovery course | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days | 
| postoperative nutritional status | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months | 
| inflammatory immune response | 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 | Preoperative 3 days and postoperative 1, 3, and 5 days | 
| Time of digestive tract reconstruction | From the beginning to the end of digestive tract reconstruction | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, robotic assisted distal gastrectomy, total robotic distal gastrectomy