3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Study Overview
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Brief Summary
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The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

Detailed Description
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A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.

Official Title
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3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

Conditions
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Splenic Hilum Lymph Nodes Dissection

Intervention / Treatment
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* Procedure: 3D Laparoscopic total gastrectomy
* Procedure: 2D Laparoscopic total gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy; cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition. Eastern Cooperative Oncology Group (ECOG): 0 or 1; American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ; Written informed consent. Exclusion Criteria: Pregnant or breast-feeding women; Severe mental disorder; Previous upper abdominal surgery (except laparoscopic cholecystectomy); Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection; Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; Other malignant disease within the past 5 years; Previous neoadjuvant chemotherapy or radiotherapy; Contraindication to general anesthesia (severe cardiac and/or pulmonary disease); Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

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: 3D Laparoscopic total gastrectomy<br>Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure: 3D Laparoscopic total gastrectomy<br>* When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection<br>* Other names: 3D-LTG;|
| Active Comparator: 2D Laparoscopic total gastrectomy<br>Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure: 2D Laparoscopic total gastrectomy<br>* When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection<br>* Other names: 2D-LTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of splenic hilum lymph nodes harvested |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complication rate | The early complication rate is defined as the event observed during operation and within 30 days after surgery. | 30 days | 
| Operative time | It will be assessed with the unit of minute. | Intraoperative | 
| Operative blood loss | It will be assessed with the unit of ml. | Intraoperative | 
| Time of splenic hilum lymph nodes dissection | It will be assessed with the unit of minute | Intraoperative | 
| Number of total lymph nodes harvested |  | 7 days | 
| Poster-operative recovery course | Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course. | 30 days | 
| Quality of life | It will be assessed with questionnaire of WHO-QOL-100 (WHO was short for world health organization) | 1 year | 
| 3-year disease free survival rate |  | 3 years | 
| 3-year overall survival rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, 3D, 2D