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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.

As part of the CARDIA-trial, two operations are compared with one another. The participants therefore undergo either a transthoracic esophagectomy or a transhiatal extended gastrectomy. Before the operation, a random generator will select the surgical procedure that the patient will undergo. This process is call randomization and will ensure that the results are objective and that half of the study participants are in both groups. During the operation, the surgeon will check whether the operation goes as planned and will lead to complete removal of the tumor and surrounding lymph nodes. This is always our primary concern. The surgery is changed if necessary to fully remove the tumor.

Before entering the study, routine examinations are performed to determine the location of the tumor and the extent of disease, and to evaluate whether the patient is suitable for participating in the CARDIA- trial. Before the operation, an endoscopic performed. The CT-scan is often combined with a PDG-PET/CT-scan. Moreover, blood samples are taken to determine the blood cell count and liver and kidney function. In addition, a pulmonary function test is carried out. An ultrasound of the heart may be performed if the patient has a cardiac disease in the medical history. These examinations are routinely performed and are necessary for every patient to determine whether the tumor can be safely treated with surgery, as for patients who do not participate in the CARDIA-trail.

If a patient participates in the study, there is no additional burden for the patient and the start of tumor therapy is not delayed. If all requirements for participating in the study are fulfilled, the participant will be randomized to one of the therapy arms. The esophagectomy consists of two phases. One phase takes place in the abdomen and the other in the chest cavity. The operation begins in the abdomen. First, the stomach is detached from its connections in the abdomen (gastrolysis) including some of the blood vessels that lead to the stomach. The stomach I later supplied via a vascular network that remains on the left side of the stomach. This makes the stomach mobile so that it can be transferred into the chest cavity in the second part of the operation. In addition, lymph nodes are removed in the abdomen along the stomach and the supplying blood vessels, because tumor cells may spread to lymph nodes. If necessary, the gastric tube formation can already take place here.

The next step is to open the chest cavity from the right. The esophagus I also detached from its connections in the chest and cut through in the upper part of the chest cavity. Again, the lymph nodes along the esophagus are removed. The stomach is then passed into the chest cavity and the esophagus and part of the upper stomach are separated (Esophagectomy). The next step is to open the chest cavity from the right. The esophagus is also detached from its connections in the chest and cut through in the upper part of the chest cavity. Again, the lymph nodes along the esophagus are removed. The stomach is then passed into the chest cavity and the esophagus and part of the upper stomach are separated (Esophagectomy). If not done earlier in the operation, the stomach tube is now formed and then connected to the remaining esophagus.

The second possible surgical procedure is the transhiatal extended gastrectomy. In this procedure, surgery is only performed in the abdomen. Here, the stomach is also detached from its surrounding connections the same way as described above, and removed with part of the lower esophagus. The rest-esophagus is then connected with a loop of the small intestine. During this operation, the lymph nodes along the stomach and the supplying vessels are removed.

Follow-up examinations for the CARDIA-trial are performed the same as regular follow-up schemes: after 1, 3, 6, 12, 18 and 24 month. In each case, an anamnesis, a physical examination, a blood test and a query about the quality of life take place. In addition, after 6, 12, 18 and 24 month, a CT scan of the chest cavity and the abdomen, as well as an endoscopy are performed. With the exception of the quality of life survey and the one-month examination, these examinations and the time intervals also correspond to the recommendations of the German guideline. Participation in the study therefore does not result in any additional burden. We understand if you have any questions about the CARDIA-trial or study procedures. Please feel free to ask your treating surgeon or the medical coordinators of the CARDIA-trial.