Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

Detailed Description
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Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Official Title
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A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Total Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy) age between 20 and 80 years old Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese written informed consent without preoperative chemotherapy and radiotherapy Exclusion Criteria: clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System history of chemotherapy, radiotherapy, immunotherapy or target therapy perigastric lymphnode≥3cm received gastric surgery (i.e. gastrectomy or gastrojejunostomy) multiple primary tumors suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. patients need emergency operation with complication of gastric cancer adhesion due to the previous intraabdominal surgery need for combined organ resection due to aggression of gastric cancer of other disease, vulnerable people who cannot communicate or are pregnant (or planning to be pregnant) currently participating or participated in other clinical trials in the last 6 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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> | Procedure: Total Gastrectomy<br>* The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.<br>|
| Active Comparator: Open Total Gastrectomy<br> | Procedure: Total Gastrectomy<br>* The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year-DFS | 3 year-disease free survival | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year-OS | 3 year-overall survival | 3 year | 
| morbidity and mortality rates | morbidity and mortality within 30 days following surgeries | 30 days following surgeries | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy