Actively Recruiting
Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
Led by Laura Boer · Updated on 2024-10-01
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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 body's 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.
CONDITIONS
Brief Title
Focal Cryoballoon Ablation for Malignant Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histopathologically confirmed esophageal or gastroesophageal cancer
- Patients in the palliative setting, with or without current or future systemic chemotherapy
- Dysphagia score of 2 or higher (able to swallow only semi-solid foods)
- Signed written informed consent
You will not qualify if you...
- Alternative causes for dysphagia other than esophageal cancer
- Inability to pass an ultraslim endoscope
- Severe medical conditions preventing endoscopy
- Uncorrected blood clotting problems
- Prior distal esophagectomy surgery
- Previous esophageal varices
- Expected survival less than 6 weeks
- Prior radiotherapy for esophageal cancer
- T4b stage esophageal cancer
- Incapacitated subjects
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks depending on number and spacing of treatments
Participants receive focal cryoballoon ablation, with 1 to 3 treatments spaced 1 to 3 weeks apart to help relieve dysphagia.
1 to 3 visits (in-person) for treatments
Duration - Up to 12 weeks after last treatment
Participants are monitored for safety, symptom relief, and other outcomes following treatment.
Multiple visits over 12 weeks for assessments
Trial Site Locations
Total: 1 location
1
UMCU
Utrecht, Netherlands
Actively Recruiting
Research Team
L
Laura S Boer, Degree of medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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