Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, Minimally-invasive, Oncological quality of resection
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Intervention
Name: Minimally-invasive gastrectomy Type: Procedure
Name: Open Gastrectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Status: Not yet recruiting
Contact: N Rahbari, MD
Academic Medical Centre
Amsterdam, NH, Netherlands
Status: Not yet recruiting
Contact: S. S. Gisbertz, MD, PhD - s.s.gisbertz@amc.uva.nl
VU Medical Center
Amsterdam, Nlnh, Netherlands
Status: Not yet recruiting
Contact: J Straatman, MD - +31 20 444 4533 - je.straatman@vumc.nl
Hospital universitari Basurto
Bilbao, Spain
Status: Recruiting
Contact: Ismael Diez del Val, MD
Hospital Jerez de la Frontera
Cadiz, Spain
Status: Recruiting
Contact: Fransisco Mateo Vallejo, MD
Hospital Universitario de Josep Trueta
Girona, Spain
Status: Recruiting
Contact: Josep Roig Garcia, MD
Hospital Universitario del Sureste de Madrid
Madrid, Spain
Status: Recruiting
Contact: A Alonso Poza, MD, PhD
Salford Royal NHS Foundation Trust
Manchester, United Kingdom
Status: Not yet recruiting
Contact: Khurshid Akhtar, MD
Start Date
December 2014
Completion Date
December 2016
Sponsors
VU University Medical Center
Source
VU University Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page