The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectom
- PDF / 989,259 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 89 Downloads / 197 Views
STUDY PROTOCOL
Open Access
The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectomy with transhiatal extended gastrectomy in adenocarcinoma of the gastroesophageal junction (GEJ) type II Jessica M. Leers1†, Laura Knepper1*† , Arjen van der Veen2, Wolfgang Schröder1, Hans Fuchs1, Petra Schiller3, Martin Hellmich3, Ulrike Zettelmeyer4, Lodewijk A. A. Brosens5, Alexander Quaas6, Jelle P. Ruurda2, Richard van Hillegersberg2 and Christiane J. Bruns1
Abstract Background: Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results. Methods: This study is a multinational, multicenter, randomized, clinical superiority trial. Patients (n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months. (Continued on next page)
* Correspondence: [email protected] † Jessica M. Leers and Laura Knepper contributed equally to this work. 1 Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937 Cologne, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence
Data Loading...
