Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Study Overview
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Brief Summary
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Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield. Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy. Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.

Official Title
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The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Minimally-invasive gastrectomy
* Procedure: Open Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or above 18 years Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent. Neoadjuvant therapy (epirubicin, cisplatin, capecitabine) Surgical resectable (T1-3, N0-1, M0) Informed consent Exclusion Criteria: Previous or coexisting cancer Previous surgery of the stomach ASA classification (American Society of Anaesthesiologists) score 4 or higher

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
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of lymph node dissection | The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations. | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications after major abdominal surgery, such as gastric resection, lead to increased morbidity and mortality. A new surgical technique should be non-inferior or even improve outcomes with regard to 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 | 
| Quality of Life | Patient Related Outcome Measures (PROMs) are of increasing importance. A new surgical technique should aim at improved PROMs, which will be measured with several questionnaires. The SF-36 and GIQLI questionnaires. | 1 and 5 days postoperatively, 3 months, 6 months and 12 months | 
| Duration of hospital admission | Minimally-invasive surgery is associated with faster patient recovery and shorter duration of hospital admission. The number of days of hospital admission will be recorded. Readmission will be registered separately. | during admission, average 2 weeks | 
| Duration of Intensive Care admission | Minimally-invasive surgery is associated with faster patient recovery, therefore we expect the number of days spent on the intensive care unit to be less in this group. | During submission, average 2 days | 
| Peri-operative blood loss | Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional 'open' group. | during surgery, 1 day | 
| Duration of Surgery | Due to the techniques associated with minimally-invasive surgery the average procedure takes longer to complete. The duration of the procedure will be registered in minutes. | Peri-operatively, 1 day | 
| Cost-effectiveness | Cost-effectiveness will be measured based on duration and equipment necessary for surgery, admission duration, ICU admission and reinterventions. | from surgery to one year follow-up | 
| Disease-free survival | In order to further assess oncological feasibility of minimally-invasive gastrectomy disease-free survival will be monitored up to 5 years postoperatively. Patients are informed, when they enter the study, that they can be contacted for additional information up to 5 years postoperatively. | up to 5 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Minimally-invasive, Oncological quality of resection