esophageal cancer esophageal carcinoma
Conditions
Interventions
For all treatments the C2 Focal CryoBalloonTM will be used. The intervention
consists of 3 subsequent treatments with an interval of 1-3 weeks. During each
treatment session, two freeze-thaw cycles
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: Alternative etiology for dysphagia including radiotherapy induced esophageal stenosis giving rise to dysphagia symptomsInability to pass ultraslim endoscope Severe medical comorbidities precluding endoscopy Uncorrected coagulopathy Prior distal esophagectomy Expected survival <6 weeks T4b esophageal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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 2. 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. 3. Safety based on incidence of all serious adverse events up to the end of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility, efficacy and safety: • Efficacy based on subjective parameters o Reported outcomes on dysphagia scores twice weekly, up to two weeks after endoscopy, and thereafter at week 6, 8 and 12. o General questions, twice weekly, up to two weeks after last treatment: * How do you experience your symptoms now compared to before treatment (0= symptoms got significantly worse, 1= symptoms got slightly worse, 2= symptoms remained the same, 3, symptoms slightly improved, 4= symptoms significantly improved, 5= symptoms fully disappeared) * How do you experience your symptoms now compared to yesterday (0= symptoms got significantly worse, 1= symptoms got slightly worse, 2= symptoms remained the same, 3, symptoms slightly improved, 4= symptoms significantly improved) • Post procedural pain based on twice weekly pain scores up to two weeks after last treatment o 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) o Pain at the area of the esophageal tumor when not eating/at rest using the same score as above • Incidence of AE*s, defined as any undesirable experience occurring to a subject following treatment and/or that are secondary to the treatment. All adverse events reported spontaneously by the subject or observed by the investigator/ staff will be recorded. • Necessity of receiving any other kind of palliation for dysphagia during follow-up Immunology: • (Changes in) Host*s anti-tumor response after cryoballoon ablation compared to baseline. | — |
Countries
Netherlands
Contacts
Public ContactL S Boer
Universitair Medisch Centrum Utrecht
Outcome results
None listed