Laparoscopic Versus Open Resection of Cancer Stomach

Study Overview
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Brief Summary
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The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). There are two main types of techniques (open & laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision. So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.

Detailed Description
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The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). # Tumor resection; Will be done by one of the following techniques: laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour) Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1): D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of < 1.5 cm in diameter; D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer < 2.0 cm in diameter with only perigastric lymph node metastasis (N1); D2 for early cancer > 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.

Official Title
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Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic gastrectomy
* Procedure: Open gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0). Exclusion Criteria: Pregnancy. Infiltration to the( pancreas ,liver ,colon or vital vascular structure). Metastasis to the (liver, lung, brain, paraaortic LN involvement). Peritoneal deposit. Surgically unfit patient.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Laparoscopic gastric cancer resection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic gastrectomy<br>Patients allocated to the 'laparoscopic Gastrectomy' group will undergo laparoscopic gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one. | Procedure: Laparoscopic gastrectomy<br>* Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.<br>* Other names: Minimally invasive gastrectomy;|
| Active Comparator: Open gastrectomy<br>Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy. This group is considered the control group | Procedure: Open gastrectomy<br>* patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of lymph nodes in the postoperative spicement. | considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Measured as 30-day mortality rate | 30 days post-operative | 
| Postoperative complications | Complications will be graded according to the Clavien-Dindo classification, which grades complications with regard to necessary treatment for this complication. Also Long-term complications, such as hernia cicatricialis will be monitored | Postoperatively with follow-up to one year | 
| Peri-operative blood loss | Laparoscopic gastrectomy is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and compared to the conventional 'open' group. | during surgery, 1 day | 
| Duration of Surgery | UsuallyLaparoscopic gastrectomy takes longer time to complete. The duration of the procedure will be registered in minutes. | Peri-operatively, 1 day |