Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Study Overview
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Brief Summary
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Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Detailed Description
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Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic total gastrectomy
* Procedure: Open 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 American Joint Committee On Cancer (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: Laparoscopic total gastrectomy<br>Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure: Laparoscopic total gastrectomy<br>* When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.<br>* Other names: LTG;|
| Active Comparator: Open total gastrectomy<br>Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection. | Procedure: Open total gastrectomy<br>* When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.<br>* Other names: OTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of group Splenic Hilum (No.10) 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 | 30 days | 
| Operative time |  | Intraoperative | 
| Operative blood loss |  | Intraoperative | 
| Time of splenic hilum lymph nodes dissection |  | Intraoperative | 
| Number of total lymph nodes harvested |  | 7 days | 
| Post-operative recovery course | Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course | 30 days | 
| 3-year disease free survival rate |  | 3 years | 
| 3-year overall survival rate |  | 3 years | 
| Quality of life | It will be assessed by questionnaire (WHO quality of life-100) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy