Clinical trial NCT02130726: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
Official title: The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric cancer
Minimally-invasive
Oncological quality of resection
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
First posted: 2014-05-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Extent of lymph node dissection
timeFrame: two weeks
Secondary outcomes:
measure: Postoperative complications
timeFrame: Postoperatively with follow-up to one year
measure: Quality of Life
timeFrame: 1 and 5 days postoperatively, 3 months, 6 months and 12 months
measure: Duration of hospital admission
timeFrame: during admission, average 2 weeks
measure: Duration of Intensive Care admission
timeFrame: During submission, average 2 days
measure: Peri-operative blood loss
timeFrame: during surgery, 1 day
measure: Duration of Surgery
timeFrame: Peri-operatively, 1 day
measure: Cost-effectiveness
timeFrame: from surgery to one year follow-up
measure: Disease-free survival
timeFrame: up to 5 years postoperatively
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
state: NH
city: Amsterdam
country: Netherlands
facility: VU Medical Center
state: Nlnh
city: Bilbao
country: Spain
facility: Hospital universitari Basurto
city: Cadiz
country: Spain
facility: Hospital Jerez de la Frontera
city: Girona
country: Spain
facility: Hospital Universitario de Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario del Sureste de Madrid
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: VU Medisch Centrum
name: D.L. van der Peet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Straatman J, van der Wielen N, Cuesta MA, Gisbertz SS, Hartemink KJ, Alonso Poza A, Weitz J, Mateo Vallejo F, Ahktar K, Diez Del Val I, Roig Garcia J, van der Peet DL. Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:123. doi: 10.1186/s13063-015-0638-9.