NCT02130726

Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Minimally-invasive gastrectomy	Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.
PROCEDURE	Open Gastrectomy	patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2014-05-05
• Last updated: 2019-07-17

Locations

8 sites across 4 countries: Germany, Netherlands, Spain, United Kingdom