Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-06-24
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cryotherapy
Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laura Boer
OTHER
Responsible Party
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Laura Boer
Principle Investigator
Locations
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UMCU
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL84764.000.23
Identifier Type: -
Identifier Source: org_study_id
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