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NCT Number: NCT02130726

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Carl Gustav Carus, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally-invasive gastrectomy

Procedure

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

Other names: laparoscopic gastrectomy

Open gastrectomy

Procedure

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

Other names: Conventional Gastrectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Stichting Nuts Ohra

Registry information

Official study title

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

Acronym: STOMACH

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 5, 2014
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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