Endoscopic-Assisted Electrochemotherapy Versus Argon Plasma Coagulation in Non-Curable Esophageal Cancer – A Randomized Clinical Trial

Abstract

Background: In this randomized clinical trial, we compared endoscopic-assisted electrochemotherapy (ECT) with argon plasma coagulation (APC) in patients suffering from esophageal cancer. We hypothesized that an initial, local tumor treatment could prevent or prolong the time to severe, obstructive dysphagia. Previous studies suggest that ablative therapies might have survival advantages compared with placing an esophageal stent. Methods: We aimed to include 50 patients with non-curable esophageal cancer. Patients were randomized to ECT or APC (1:1) as an upfront treatment and hereafter referred for standard treatment. The primary endpoint was the difference in time to interventional treatment demanding dysphagia. Secondary endpoints included side effects, symptom palliation, tumor response, and survival. Results: Ten patients were included (the study was prematurely terminated due to recruitment challenges), and the results are, therefore, mainly exploratory. Five patients received ECT, and four patients received APC. The median survival time among all patients was ten months. Two patients in the APC group and no patients in the ECT group had an esophageal stent placed during the follow-up period. One month after treatment, dysphagia relief was observed in five patients (two patients in the ECT group), and four patients had a partial response evaluated from CT imaging (three patients from the ECT group). No severe adverse events were registered in either group. Conclusion: ECT and ACP were administrated as initial therapy with few side effects, and none of the patients in the ECT group developed interventional treatment demanding dysphagia during their remaining lifetime. Future studies with ECT should focus on both symptom palliation, the need for re-intervention, and survival.