Mueller Tara C, Schirren Rebekka, Kehl Victoria, Friess Helmut, Reim Daniel, Martignoni Marc E
Department of Surgery, Technical University of Munich School of Medicine Klinikum rechts der Isar, Ismaninger Straße 22, 81675, München, Germany.
Institute for Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, 81675, Munich, Germany.
Trials. 2017 Dec 28;18(1):621. doi: 10.1186/s13063-017-2388-3.
The majority of patients with gastric or esophago-gastric cancer are at risk for malnutrition. Preoperative malnutrition was shown to increase the incidence of postoperative complications following abdominal surgery. However, it remains unclear if preoperative parenteral nutritional support during neoadjuvant chemotherapy (NACT) may be effective to reduce the rate of postoperative complications in these patients.
METHODS/DESIGN: The PERCOG trial is a randomized controlled multicenter observer-blinded trial, investigating if the improvement of the general condition of patients with non-metastasized gastric cancer or cancer of the esophago-gastric junction during NACT by supplemental parenteral nutrition can decrease the postoperative Comprehensive Complication Index (CCI). Statistical analysis of the primary endpoint measure (CCI on postoperative day 30) will be based on the intention-to-treat population. The global level of significance is set at 5% and the sample size (n = 150) is determined to assure a power of 80%.
The results of the PERCOG trial will provide high-level evidence for clinical recommendations regarding the administration of preoperative supportive parenteral nutrition and provide all participating patients the opportunity of an improved treatment.
German Clinical Trials Register, DRKS00009451 . Registered on 3 July 2017.
大多数胃癌或食管胃癌患者存在营养不良风险。术前营养不良已被证明会增加腹部手术后的术后并发症发生率。然而，新辅助化疗（NACT）期间术前肠外营养支持是否能有效降低这些患者的术后并发症发生率仍不清楚。
方法/设计：PERCOG试验是一项随机对照多中心观察者盲法试验，研究在NACT期间通过补充肠外营养改善非转移性胃癌或食管胃交界癌患者的一般状况是否能降低术后综合并发症指数（CCI）。主要终点指标（术后30天的CCI）的统计分析将基于意向性治疗人群。显著性的总体水平设定为5%，样本量（n = 150）经确定以确保80%的检验效能。
PERCOG试验的结果将为术前支持性肠外营养的临床应用提供高级别证据，并为所有参与试验的患者提供改善治疗的机会。
德国临床试验注册中心，DRKS00009451。于2017年7月3日注册。
