Focal Cryoballoon Ablation for Malignant Dysphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaura Boer
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Alternative etiology for dysphagia
Inability to pass the ultraslim endoscope
Severe medical comorbidities precluding endoscopy
Uncorrected coagulopathy
Trial design
Design model
Single group
Treatments tested in this trial
Cryotherapy
Procedure/SurgeryFocal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary outcome safety
Safety based on incidence of all procedure related serious adverse events up to the end of follow-up. The technique is considered to be safe if ≥80% of the procedures is performed without the occurrence of procedure-related serious adverse events.
Time frame
2 weeks2
primary outcome efficacy
Efficacy * Subjective parameters based on clinical success rate at week 2 after last therapy, using the 5 point Likert dysphagia score (0= no dysphagia, 1= dysphagia to solids, 2= dysphagia to semisolids, 3= dysphagia to liquids, 4= dysphagia to saliva). An improvement of one point is considered as clinical success. * Objective parameters: * Ability of the diagnostic endoscope to pass * Percentage of the diameter of the esophageal lumen that is open/ free from tumor, as assessed by the treating endoscopist and two independent assessors, comparing pre- and post-treatment.
Time frame
2 weeks3
primary outcome feasibility
Feasibility: defined as technical success rates of a full cryotherapy procedure. This includes the ability to pass the scope and the completion of a full circle of freezing and thawing, with the number of cycles needed per site as deemed necessary by the endoscopist. The technique is considered to be feasible if ≥70% of the procedures is technically successful.
Time frame
1 daySecondary outcomes
1
secondary outcome efficacy subjective
General questions, twice weekly, up to two weeks after last treatment: * How do you experience your symptoms now compared to before treatment (0= fully disappeared, 1= symptoms significantly improved, 2= symptoms slightly improved, 3 = symptoms remained the same, 4= symptoms got slightly worse, 5= symptoms got significantly worse) * How do you experience your symptoms now compared to yesterday (0= symptoms significantly improved, 1= symptoms slightly improved, 2= symptoms remained the same, 3, symptoms got slightly worse, 4= symptoms got significantly worse)
Time frame
2 weeks2
secondary outcome efficacy subjective
Reported outcomes on dysphagia scores twice weekly, up to two weeks after endoscopy, and thereafter at week 6, 8 and 12.
Time frame
12 weeks3
secondary outcome pain
Post procedural pain based on twice weekly pain scores up to two weeks after last treatment * Pain at the area of the esophageal tumor during meals based on a NRS 0-10 (with 0 indicating no pain and 10 indicating unbearable pain) * Pain at the area of the esophageal tumor when not eating/at rest using the same score as above
Time frame
2 weeks4
secondary outcome safety
Incidence of all (S)AE's
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laura Boer
Lead sponsor
UMC Utrecht
Sponsor institution
Source ClinicalTrials.gov