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

July 16, 2019 updated by: J. Straatman, Amsterdam UMC, location VUmc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus
  • Netherlands
    • NH
      • Amsterdam, NH, Netherlands, 1105AZ
        • Academic Medical Centre
    • Nlnh
      • Amsterdam, Nlnh, Netherlands, 1081HV
        • VU Medical Center
  • Spain
      • Bilbao, Spain
        • Hospital universitari Basurto
      • Cadiz, Spain
        • Hospital Jerez de la Frontera
      • Girona, Spain
        • Hospital Universitario de Josep Trueta
      • Madrid, Spain
        • Hospital Universitario del Sureste de Madrid
  • United Kingdom
      • Manchester, United Kingdom
        • Salford Royal NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Minimally-invasive gastrectomy
Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.
Other Names:
  • laparoscopic gastrectomy
Active Comparator: 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
Procedure: Open Gastrectomy
patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy
Other Names:
  • Conventional Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of lymph node dissection
Time Frame: 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.
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 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.
Postoperatively with follow-up to one year
Quality of Life
Time Frame: 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.
1 and 5 days postoperatively, 3 months, 6 months and 12 months
Duration of hospital admission
Time Frame: 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.
during admission, average 2 weeks
Duration of Intensive Care admission
Time Frame: 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.
During submission, average 2 days
Peri-operative blood loss
Time Frame: 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.
during surgery, 1 day
Duration of Surgery
Time Frame: 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.
Peri-operatively, 1 day
Cost-effectiveness
Time Frame: 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.
from surgery to one year follow-up
Disease-free survival
Time Frame: 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.
up to 5 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Stichting Nuts Ohra

Investigators

  • Principal Investigator: D.L. van der Peet, MD, PhD, VU Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOMACH trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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