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Trials

, 16:123

First Online: 27 March 2015Received: 20 October 2014Accepted: 05 March 2015DOI: 10.1186-s13063-015-0638-9

Cite this article as: Straatman, J., van der Wielen, N., Cuesta, M.A. et al. Trials 2015 16: 123. doi:10.1186-s13063-015-0638-9

Abstract

BackgroundLaparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear.

Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield.

Methods-DesignThe Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy STOMACH study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable T1-3, N0-1, M0 after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures PROMs regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of −4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included.

DiscussionThe STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional ‘open’ approach or minimally invasive total gastrectomy.

Trial registrationThis trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726.

KeywordsGastric cancer Gastrectomy Minimally invasive surgery AbbreviationsASAAmerican Society of Anesthesiologist classification

EORTCEuropean Organisation for Research and Treatment of Cancer questionnaires

EQ-5DEuro-Qol Quality of Life-5D questionnaire

ICUIntensive care unit

NKRNederlandse Kanker Registratie Dutch Cancer Registry

PCAPatient-controlled analgesia

PROMsPatient-reported outcome measurements

STOMACHThe surgical techniques, open versus minimally invasive gastrectomy after chemotherapy trial

VUmcVU University Medical Center

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Autor: Jennifer Straatman - Nicole van der Wielen - Miguel A Cuesta - Suzanne S Gisbertz - Koen J Hartemink - Alfredo Alonso Poz

Fuente: https://link.springer.com/







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