RecruitingNot ApplicableNCT06618742

Focal Cryoballoon Ablation for Malignant Dysphagia

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


Sponsor

Laura Boer

Enrollment

20 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing focal cryoballoon ablation — a procedure that uses extreme cold delivered through a balloon to destroy cancerous tissue in the esophagus — as a palliative treatment for people who have difficulty swallowing (dysphagia) due to esophageal or stomach-junction cancer. The goal is to help patients swallow more comfortably. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with esophageal or gastroesophageal junction cancer confirmed by biopsy - You are in the palliative care setting (the cancer is not being treated to cure) - You have significant difficulty swallowing — you can only manage semi-solid foods or worse - You have given written informed consent **You may NOT be eligible if...** - Your swallowing difficulty has a different cause - The endoscope cannot physically pass through to the affected area - You have serious health conditions that would make an endoscopy unsafe - You have uncorrected blood clotting problems - You have had prior surgery on the lower esophagus or have a history of esophageal varices - You have T4b esophageal cancer (tumor involving surrounding structures) - You are pregnant or breastfeeding - Your expected survival is less than 6 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECryotherapy

Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks


Locations(1)

UMCU

Utrecht, Netherlands

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NCT06618742


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