Clinical trial · Interventional
Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally-invasive gastrectomy | Procedure | — | UNRESOLVED |
| Open Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Minimally-invasive Gastrectomy
- description
- Patients allocated to the 'Minimally-invasive Gastrectomy' group will undergo minimally-invasive/laparoscopic total gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one.
- interventionNames
- Procedure: Minimally-invasive gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Open Gastrectomy
- description
- Patients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group
- interventionNames
- Procedure: Open Gastrectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDvan der Wielen N, Daams F, Rosati R, Parise P, Weitz J, Reissfelder C, Del Val ID, Loureiro C, Parada-Gonzalez P, Pintos-Martinez E, Vallejo FM, Achirica CM, Sanchez-Pernaute A, Campos AR, Bonavina L, Asti ELG, Poza AA, Gilsanz C, Nilsson M, Lindblad M, Gisbertz SS, van Berge Henegouwen MI, Romario UF, De Pascale S, Akhtar K, Cuesta MA, van der Peet DL, Straatman J. Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial. Surg Endosc. 2023 Sep;37(9):7317-7324. doi: 10.1007/s00464-023-10278-5. Epub 2023 Jul 19. PMID 37468751
- DERIVEDStraatman 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. PMID 25873249