STOMACH Trial
Research type
Research Study
Full title
Surgical Techniques: Open versus Minimally-invasive gastrectomy After Chemotherapy (STOMACH) Trial
IRAS ID
163816
Contact name
Khurshid Akhtar
Contact email
Sponsor organisation
VU University Medical Center
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
Background
Stomach (gastric) cancer is diagnosed in over 7,000 people every year in the UK. Surgery is the only curative option, and is offered to patients whose cancer has not spread to organs beyond the stomach. The current recommended treatment for these patients consists of removing the stomach (known as a total gastrectomy) or part of the stomach (subtotal gastrectomy) as well as surrounding lymph nodes (lymphadenectomy) that may contain cancerous cells. Surgery is usually performed following a course of chemotherapy known as neo-adjuvant chemotherapy.
In treating many cancers, keyhole, or ‘minimally-invasive’, surgery has been shown to be better when compared to open procedures. For example there is less blood loss and faster patient recovery. In terms of how effectively the cancer itself is removed, there is no difference in results between a minimally-invasive or open surgery. In gastric cancer, however, the role of minimally-invasive surgery remains unclear.Objective
The proposed study is to determine whether minimally-invasive total gastrectomy is better when compared to open gastrectomy for gastric cancer in terms of tumour clearance and postoperative complications.
Study design
The STOMACH trial is an international ‘randomized controlled trial’ designed and led by the VU University Medical Centre in Amsterdam. As a participating centre, we will ask all adult patients who are diagnosed with gastric cancer and are offered surgery (total gastrectomy) following neo-adjuvant therapy to be part of the study. Participants will be randomly assigned into two groups; one group will undergo minimally-invasive total gastrectomy, whereas the other group will undergo open total gastrectomy. The main result, or endpoint, of the study will be an assessment of the completeness of the cancer resection, including the stomach itself and the surrounding lymph nodes. We will also be looking at postoperative complications, quality of life and the overall cost-effectiveness of the surgery.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0415
Date of REC Opinion
1 Jun 2015
REC opinion
Favourable Opinion