MedTrace Logo

Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

NCT02130726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-07-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Stichting Nuts Ohra

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • D.L. van der Peet, MD, PhD · VU Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-03-31
Completion
2019-06-30

Countries

  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130726 on ClinicalTrials.gov