Cryoballoon Ablation to Relieve Dysphagia in Adults with Advanced Esophageal Cancer A Pilot Study to Assess Safety, Feasibility, and Immune Effects

What this Trial Is About

Researchers are studying the use of focal cryoballoon ablation to help relieve dysphagia difficulty swallowing in adults with incurable esophageal cancer. This pilot, multi-center, prospective study aims to assess the feasibility, safety, and effectiveness of this treatment, as well as its potential impact on the bodys anti-tumor immune response. Current palliative options like stenting and radiotherapy have drawbacks, so this study explores cryotherapy as a possible alternative. Participants will receive cryoballoon ablation during an upper endoscopy, targeting visible tumor areas. Treatment involves two cycles of freezing lasting 12 seconds each. Patients can undergo between one to three treatment sessions spaced 1 to 3 weeks apart, depending on symptom severity. The study focuses on technical success, side effects, and symptom improvement following these procedures. Throughout the study, patients will be monitored for procedure safety and dysphagia improvement at 2 and 12 weeks after treatment. Researchers will also collect esophageal tumor biopsies and blood samples to evaluate immune responses. The total follow-up includes assessments of pain, other palliative effects, and longer-term safety, with the main outcomes measured shortly after the last treatment session.

Focal Cryoballoon Ablation for Malignant Dysphagia