Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer

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 distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Detailed Description
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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 distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.

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

Conditions
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Stomach Neoplasm, Robotic Surgery

Intervention / Treatment
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* Procedure: Robotic Distal Gastrectomy
* Procedure: Laparoscopic 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 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 Distal Gastrectomy<br>Robotic Distal Gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Robotic Distal Gastrectomy<br>* After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.<br>|
| Active Comparator: Laparoscopic Distal Gastrectomy<br>Laparoscopic Distal Gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Laparoscopic Distal Gastrectomy<br>* After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.<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 | the rate of 3-year disease free survival | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival rate | the rate of 3-year overall survival rate | 36 months | 
| 3-year recurrence pattern | the pattern of recurrence in 3 years | 36 months | 
| overall postoperative morbidity rates | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days | 
| 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 | 
| number of retrieved lymph nodes | number of retrieved lymph nodes | 1 days | 
| the noncompliance rate of lymphadenectomy | the noncompliance rate of lymphadenectomy | 1 days | 
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days | 
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days | 
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days | 
| The variation of weight | The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months | 
| The variation of cholesterol | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months | 
| The variation of album | The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months | 
| The variation of white blood cell count | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. | Preoperative 7 days and postoperative 1 and 5 days | 
| The variation of hemoglobin | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. | Preoperative 7 days and postoperative 1 and 5 days | 
| Hospitalization expenses | The cost from admission to discharge | 30 days | 
| operation time | operation time | 1 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasm, Robotic Surgery, Distal Gastrectomy