Gastric Cancer
Conditions
Keywords
Gastric cancer, Minimally-invasive, Oncological quality of resection
Brief summary
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.
Interventions
PROCEDUREMinimally-invasive gastrectomy
Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.
PROCEDUREOpen Gastrectomy
patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy
Sponsors
Stichting Nuts Ohra
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of lymph node dissection | two weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 1 and 5 days postoperatively, 3 months, 6 months and 12 months | 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. |
| Duration of hospital admission | during admission, average 2 weeks | 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. |
| Duration of Intensive Care admission | During submission, average 2 days | 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. |
| Postoperative complications | Postoperatively with follow-up to one year | 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. |
| Duration of Surgery | Peri-operatively, 1 day | 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. |
| Cost-effectiveness | from surgery to one year follow-up | Cost-effectiveness will be measured based on duration and equipment necessary for surgery, admission duration, ICU admission and reinterventions. |
| Disease-free survival | up to 5 years postoperatively | 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. |
| Peri-operative blood loss | during surgery, 1 day | 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. |
Countries
Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed