Cryoballoon treatment for swallowing difficulties in esophageal cancer patients
Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
This study is testing if a new cryoballoon treatment can help ease swallowing difficulties for patients with esophageal cancer to improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06618742 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of cryoballoon ablation as a palliative treatment for dysphagia in patients with esophageal carcinoma. Dysphagia, a common symptom in these patients, significantly affects their quality of life and can lead to malnutrition. The study aims to assess the effectiveness of this novel cryotherapy approach compared to traditional palliative treatments, which often have considerable drawbacks. By exploring the potential immunologic benefits of cryotherapy, the study seeks to provide new insights into managing dysphagia in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathologically-confirmed esophageal or gastroesophageal cancer experiencing moderate to severe dysphagia.
Not a fit: Patients with alternative causes of dysphagia, severe comorbidities, or those who have undergone prior esophageal surgeries may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dysphagia due to esophageal cancer.
How similar studies have performed: While previous studies have shown promise with cryotherapy for dysphagia, this specific approach using cryoballoon ablation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Laura S Boer, Degree of medicine
- Email: l.s.boer-17@umcutrecht.nl
- Phone: 0887550224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.