Focal Cryoballoon Ablation for Malignant Dysphagia (DYS-CBAS)

Laura Boer

Status: Enrolling

Conditions: Dysphagia; Esophageal Cancer; Cryotherapy

Treatments: Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06618742

NL84764.000.23

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)