手术技术，化疗后开放与微创胃切除术（STOMACH试验）：一项随机对照试验的研究方案
Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.
作者信息
Straatman Jennifer, van der Wielen Nicole, Cuesta Miguel A, Gisbertz Suzanne S, Hartemink Koen J, Alonso Poza Alfredo, Weitz Jürgen, Mateo Vallejo Fransico, Ahktar Khurshid, Diez Del Val Ismael, Roig Garcia Josep, van der Peet Donald L
机构信息
Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, NL, Netherlands.
Department of Surgery, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, NL, Netherlands.
出版信息
Trials. 2015 Mar 27;16:123. doi: 10.1186/s13063-015-0638-9.
BACKGROUND
Laparoscopic 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/DESIGN: The 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.
DISCUSSION
The 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 REGISTRATION
This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .
背景
与开放手术相比，腹腔镜手术在治疗多种恶性疾病方面已显示出重要优势，如围手术期失血更少、患者恢复更快。在肿瘤切除边缘和肿瘤学长期生存率方面也能保持相似的结果。在胃癌中，腹腔镜手术的作用仍不明确。目前推荐的胃癌治疗方法包括胃的根治性切除，距肿瘤边缘5至6厘米的切缘，同时进行淋巴结清扫。淋巴结清扫的范围被认为是手术根治性和医疗质量的一个标志。因此，一种新的手术技术，如微创全胃切除术，在手术根治性和淋巴结收获量方面必须不劣于传统手术。
方法/设计：“化疗后开放与微创胃切除术的手术技术（STOMACH）”研究是一项随机、临床多中心试验。所有经新辅助化疗后肿瘤被认为可手术切除（T1 - 3，N0 - 1，M0）的成年原发性胃癌患者均有资格纳入并随机分组。主要终点是肿瘤切除的质量，通过手术根治性和回收淋巴结数量来衡量。病理学家对患者的分组情况不知情。次要结局包括患者报告的关于生活质量、术后并发症和成本效益的结局指标（PROMs）。基于淋巴结收获量的非劣效性模型，平均淋巴结收获量为20，非劣效界值为 -4，检测非劣效性的效能为90%，共纳入168例患者。
讨论
STOMACH试验是一项前瞻性、多中心、平行随机研究，旨在确定新辅助治疗后近端或中部胃癌患者的最佳手术策略：传统的“开放”方法或微创全胃切除术。
试验注册
该试验于2014年4月28日在Clinicaltrials.gov注册，标识符为NCT02130726。
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