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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
UMCU
RECRUITING
Utrecht
Contact Information
Primary
Laura S Boer, Degree of medicine
l.s.boer-17@umcutrecht.nl
0887550224
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Sponsors
Leads: Laura Boer

This content was sourced from clinicaltrials.gov