NCT06618742 Focal Cryoballoon Ablation for Malignant Dysphagia
| NCT ID | NCT06618742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laura Boer |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-06-24 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06618742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06618742 currently recruiting?
Yes, NCT06618742 is actively recruiting participants. Contact the research team at l.s.boer-17@umcutrecht.nl for enrollment information.
Where is the NCT06618742 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT06618742 clinical trial?
NCT06618742 is sponsored by Laura Boer. The trial plans to enroll 20 participants.