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We in the CARDIA study team are very pleased that you are interested or participating in the CARDIA-trial. We have summarized all important information about our study for you on this website. If you need any further information, please do not hesitate to get in touch with our medical coordinators. 

Background

The incidence of adenocarcinomas of the gastroesophageal junction (Siewert type II tumors) is increasing in the Western world. In 27% of cases, adenocarcinoma of the gastroesophageal junction is a Siewert type II tumor, which is defined when its epicenter is between ≤ 1 cm proximal and ≤ 2 cm distal from the gastroesophageal junction (Figure 1). The surgical strategies for Siewert type I and type III tumors are clearly established in the guidelines (Figure 2). For Siewert type I tumors a transthoracic esophagectomy is performed, and patients with Siewert type III tumors undergo a transhiatal extended gastrectomy. There are currently two possible surgical strategies for Siewert type II tumors: to perform a transthoracic esophagectomy or a transhiatal extended gastrectomy (Figure 2). The scientific evidence which surgical strategy leads to better survival and R0-resections is based on retrospective studies.

The CARDIA-Trial

The CARDIA-trial is a prospective, multicenter, multinational, non-inferiority randomized controlled trial. The aim of the study is to compare the oncological effectiveness and safety of transhiatal extended gastrectomy versus transthoracic esophagectomy in patients with Siewert type II tumors. The primary endpoint is overall survival. Secondary endpoints are radical resection rate (R0), postoperative complications, number and location of infiltrated lymph nodes, disease-free survival, quality of life and cost effectiveness.

We plan to enroll 262 patients. Currently, 9 German and 4 international center are open for inclusion (Table 1). The inclusion and exclusion criteria of the CARDIA trial can be found in the download area under V1.

Table 1: Current study centers and recruitment status, as of 06/2023