Clinical Research Directory

Focal Cryoballoon Ablation for Malignant Dysphagia

Sponsor: Laura Boer

Summary

Rationale: Dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment. Current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely/ temporary symptom improvement. Recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. Moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. However, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. Secondly, cryo-immunologic data in patients with EC is lacking. Objective: 1. To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed. 2. To evaluate the effect of cryoballoon ablation on host's anti-tumor response. Study design: Pilot study, Multi-center Prospective Uncontrolled Intervention Study Study population: Adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma Intervention (if applicable): Focal cryoballoon ablation of visible tumor during an upper endoscopy. Cryoballoon ablation will be performed for two cycles of 12 seconds. In total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient. Main study parameters/endpoints: * \- Feasibility of cryoballoon ablation defined as technical success of the procedure * Safety based on incidence of procedure-related serious adverse events * Efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor * Host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples

Official title: Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer

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