Focal Cryoballoon Ablation for Malignant Dysphagia

Trial Title: Focal Cryoballoon Ablation for Malignant Dysphagia

NCT ID: NCT06618742

Condition: Dysphagia
Esophageal Cancer
Cryotherapy

Conditions: Official terms:
Esophageal Neoplasms
Deglutition Disorders

Conditions: Keywords:
cryoballoon ablation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Cryotherapy
Description: Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks

Other name: cryoballoon ablation

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age >18 years at time of consent - Histopathologically-confirmed esophageal / gastroesophageal cancer - Patients in the palliative setting (with or without (future) systemic chemotherapy) - Dysphagia defined as a score of ≥2 (able to swallow only semi-solids) - Signed written informed consent Exclusion Criteria: - Alternative etiology for dysphagia - Inability to pass the ultraslim endoscope - Severe medical comorbidities precluding endoscopy - Uncorrected coagulopathy - Prior distal esophagectomy - Previous esophageal varices - Expected survival <6 weeks - Prior radiotherapy for esophageal cancer - T4b esophageal cancer - Incapacitated subjects - Pregnant or breastfeeding

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UMCU

Address:
City: Utrecht
Country: Netherlands

Status: Recruiting

Contact:
Last name: Laura S Boer, Degree of medicine

Phone: 0887550224
Email: l.s.boer-17@umcutrecht.nl

Start date: June 24, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Laura Boer
Agency class: Other

Source: UMC Utrecht

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06618742