Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy (STOMACH)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: Minimally-invasive gastrectomy; Procedure: Open Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02130726

STOMACH trial

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Minimally-invasive Gastrectomy

Experimental group

Description:

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.

Treatment:

Procedure: Minimally-invasive gastrectomy

Open Gastrectomy

Active Comparator group

Description:

Patients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group

Treatment:

Procedure: Open Gastrectomy