Goal of the STOMACH trial (Surgical Technique, Open versus Minimally-invasive gastrectomy After CHemotherapy) is to establish the optimal surgical strategy in the treatment of gastric cancer. A minimally-invasive total gastrectomy will be compared…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As posed in the background information, it is imperative that a new surgical
technique has similar results with regard to quality of oncological resection.
The primary endpoint in the STOMACH trial is therefore quality of concological
resection, as measured by radicality of surgery, the number of resected lymph
nodes and the number of resected lymph nodes stations.
Secondary outcome
Secondary endpoint in the STOMACH trial consist of postoperative complications
according to the Clavien-Dindo classification, mortality, duration of hospital
admission and 3-year survival. Along with quality of life as measured with
Patient Related Outcome Measures (PROMs); the EQ-5D, and EORTC-QLQ30 and STO22
questionnaires. Furthermore, a cost-efficiciency analysis will be conducted.
Background summary
Aim of this prospective randomised, multi-center trial is to compare open
gastrectomy with minimally invasive gastrectomy for gastric cancer in patients
that received neoadjuvant 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.
Several studies have focussed on laparoscopic versus open gastrectomy. These
studies are predominantly conducted in Asian countries, where incidence of
gastric cancer is higher. The screening program in Japan has enabled early
detection and treatment of gastric carcinomas. As such, tumour stages are lower
at the time of diagnosis compared to Western countries. Therefore it is
difficult to translate the results of Asian studies to the Western population.
Only a few Western studies were conducted that compare laparoscopic and open
approaches for gastric cancer. An important previous finding is that
laparoscopic gastrectomy showed similar results to open gastrectomy with regard
to quality of oncological resection and survival, whereas patient recovery was
faster. The studies were, however, small and underpowered. Moreover, the
studies focussed on distal gastrectomy rather than total gastrectomy.
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, such as minimally-invasive
total gastrectomy, should be non-inferior with regard to radicality and lymph
node yield.
The STOMACH trial aims to establish the optimal surgical technique in the
treatment of gastric cancer, the open approach or the minimally-invasive
approach
Study objective
Goal of the STOMACH trial (Surgical Technique, Open versus Minimally-invasive
gastrectomy After CHemotherapy) is to establish the optimal surgical strategy
in the treatment of gastric cancer. A minimally-invasive total gastrectomy will
be compared to a conventiona; 'open' resection.
Study design
STOMACH is a randomized controlled, double blinded, parallel, international
multi-center, non-inferiority trial. Patients with gastric cancer and an
indication for total gastrectomy after neoadjuvant therapy will be randomised
in two groups; open gastrectomy versus minimally invasive gastrectomy.
Randomisation will be stratified per participating center. Patients will be
enrolled from 6 international hospitals.
In order to obtain 90% power and a significance level of 0,05 a total of 96
patients are to be included, 48 allocated to each arm
Intervention
The intervention to be researched in the STOMACH trial is minimally-invasive
total gastrectomy. This will be compared to the control intervention,
conventional 'open' total gastrectomy.
In minimally-invasive total gastrectomy the stomach is operated on via 5 small
incisions. Trocars are inserted in these incisions to allow for insertion of a
camera and instruments in the abdomen. After stomach is resected, one of the
incisions is slightly enlarged in order to remove the specimen from the abdomen
Study burden and risks
The STOMACH trial compares a minimally-invasive gastrectomy with a conventional
'open' resection. Research will show whether a minimally-invasive technique is
feasible in gastric resection for cancer. Long term results regarding both
techniques will establish the optimal surgical strategy, especially
disease-free survival.
A minimally-invasive procedure usually lasts longer than a conventional
procedure. Minimally-invasive techniques are not associated with increased risk
of complications. Both techniques are associated with normal risks associated
with surgery. Sometimes a minimally-invasive procedure does not seem feasible,
for example due to adhesions. The operation will be converted to a conventional
'open' approach
It could be possible that an extra venous puncture is necessary (max 3 times)
for research of immunology.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age equal to or above 18 years. Patients with primary adenocarcinoma of the stomach, with an indication for total gastrectomy. The tumour is considered surgically resectable (T1-2, N0-1, M0). Patients have received neoadjuvant chemotherapy (all therapeutic regimens are allowed). Patients are able to give informed consent.
Exclusion criteria
Patients with previous or coexisting cancer. Patients who have had previous surgery of the stomach. Patients who are not deemed suitable for minimally-invasive surgical techniques by the operating surgeon, Patients with an ASA-score (American Society of Anaesthesiologists) of 4 or higher
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02130726 |
| CCMO | NL51293.029.14 |