Patient information
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In the study described below, two established surgical procedures are compared. The clinical trial that we would like to present to you was approved by the central medical ethics committee of the University Medical Center Cologne, and by the institutional review board of all participating centers. The study will be performed in 13 hospitals and 262 patients will be included. The study is initiated and organized by the University of Cologne and financed by the Federal Ministry of Education and Research, Germany. The University Medical Center Cologne and University Medical Center Utrecht coordinate the CARDIA-trial.
Clinical studies are essential in order to gain or expand scientific knowledge about the effectiveness, safety and feasibility of surgical procedure. Participation in a clinical study is voluntary. Patients will only be included in a study after they have been fully informed and if they have given their written consent. The information on our website is intended to inform you about our CARDIA trial. The CARDIA-trial fulfills to all (inter) national privacy, ethical and regulatory conditions required by law. If you have any further questions afterwards, please do not hesitate to contact the listed medical coordinators.
The CARDIA-trial is designed for patients with tumors located directly at the transition part between esophagus and stomach (gastro-esophageal junction, GEJ). Complete surgical removal of the tumor and surrounding lymph nodes is necessary to cure this cancer. There are currently two possible surgical procedures to achieve complete removal of the tumor and surrounding lymph nodes: the transthoracic esophagectomy (TTE) with gastric tube reconstruction or transhiatal extended gastrectomy (TEG) with Roux-en-Y reconstruction. So far, it has not yet been scientifically proven which of the two operations is better suited for treating Siewert type II tumors. Both operations are recommended as equivalent treatment methods in current treatment guidelines. The aim of the randomized controlled CARDIA-trial is therefore to compare these two procedures (TTE versus TEG) in terms of oncological efficacy, postoperative recovery and quality of life. As a result of the CARDIA-trial, all future patients with Siewert type II tumors can be offered the best possible surgical procedure with a solid scientific basis.