Prophylactic endoscopic pylorus dilatation prior to esophagectomy for esophageal cancer to prevent delayed gastric emptying, study protocol for a placebo-controlled randomized trial (PROPPER trial).
C Mann, F Berlth, V J Lozanovski, M Passalacqua, E Hadzijusufovic, E Uzun, G Capovilla, M Valmasoni, H Lang, P P Grimminger
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引用次数: 0
Abstract
Introduction: Delayed gastric emptying (DGE) due to pyloric dysfunction remains a common postoperative complication after esophagectomy for cancer and can lead to severe secondary complications. As shown in a retrospective study, prophylactic EPBD performed 1 day before surgery can reduce the rate of postoperative DGE by reducing pyloric resistance. The objective of this study is to analyze the effect of prophylactic EPBD on postoperative DGE rates in patients receiving minimally invasive esophagectomy for cancer by gastric pull-up.
Methods: This study is designed as a multicenter randomized controlled trial (RCT) including patients with esophageal cancer or cancer of the gastroesophageal junction (adenocarcinoma and squamous cell carcinoma, with or without neoadjuvant treatment) scheduled for minimally invasive esophagectomy with gastric pull-up. After randomization, patients will either receive preoperative EPBD or a sham intervention in the routine preoperative endoscopy performed 1 day before surgery. The primary endpoint of this study will be rates of DGE, particularly those resulting from pyloric dysfunction, requiring intervention. Secondary outcomes will be major and minor postoperative complication rates, in-hospital mortality, adverse events during gastroscopy, length of ICU and hospital stay as well as postoperative pain and quality of life. In order to detect a difference between both groups at a two-sided 5% significance level, to achieve a power of 0.8 with a calculated dropout rate of approximately 20%, a sample size of 118 patients with 59 patients in every study arm will be needed.
Discussion: The presented PROPPER trial is the first multicenter RCT that will provide evidence regarding the efficacy of preoperative EPBD in reducing DGE after minimally invasive esophagectomy for cancer.
Trial registration: This trial was registered in the German Clinical Trials Register (DRKS), under the identifier DRKS00034360. Registered on May 29, 2024. The WHO trial registration data set can be found here: http://drks.de/search/en/trial/DRKS00034360 .
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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