Focal Cryoballoon Ablation for Malignant Dysphagia

Study acronym: DYS-CBAS
StatusUnknown
PhaseNot applicable
SponsorLaura Boer
Started

Record status This record was last updated October 1, 2024 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06618742
Lead Sponsor Laura Boer
Conditions
(from sponsor)
Dysphagia, Esophageal Cancer, Cryotherapy
Related terms Deglutition Disorders, Esophageal Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov