Clinical trial NCT06618742: Focal Cryoballoon Ablation for Malignant Dysphagia
Official title: Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Esophageal Cancer
Cryotherapy
Keywords: cryoballoon ablation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \&amp;gt;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 \&amp;lt;6 weeks
* Prior radiotherapy for esophageal cancer
* T4b esophageal cancer
* Incapacitated subjects
* Pregnant or breastfeeding

Primary outcomes:
measure: Primary outcome safety
timeFrame: 2 weeks
measure: primary outcome efficacy
timeFrame: 2 weeks
measure: primary outcome feasibility
timeFrame: 1 day
Secondary outcomes:
measure: secondary outcome efficacy subjective
timeFrame: 2 weeks
measure: secondary outcome efficacy subjective
timeFrame: 12 weeks
measure: secondary outcome pain
timeFrame: 2 weeks
measure: secondary outcome safety
timeFrame: 12 weeks
measure: secondary outcome other palliation
timeFrame: 12 weeks
measure: Secondary outcome immunology
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
References: