Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-06-30

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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Minimally-invasive Gastrectomy

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.

Group Type EXPERIMENTAL

Minimally-invasive gastrectomy

Intervention Type PROCEDURE

Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.

Open Gastrectomy

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

Group Type ACTIVE_COMPARATOR

Open Gastrectomy

Intervention Type PROCEDURE

patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy

Interventions

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Minimally-invasive gastrectomy

Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.

Intervention Type PROCEDURE

Open Gastrectomy

patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic gastrectomy Conventional Gastrectomy

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