Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Gastric Cancer Clinical Trial

— STOMACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130726
• Other study ID #: STOMACH trial
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Minimally-invasive gastrectomy
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 gastrectomy via laparotomy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Stichting Nuts Ohra

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of lymph node dissection	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	Postoperative complications	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
Secondary	Quality of Life	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
Secondary	Duration of hospital admission	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
Secondary	Duration of Intensive Care admission	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
Secondary	Peri-operative blood loss	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
Secondary	Duration of Surgery	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
Secondary	Cost-effectiveness	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
Secondary	Disease-free survival	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

External Links

•   STOMACH trial