Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618742
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Focal Cryoballoon Ablation for Malignant Dysphagia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYS-CBAS
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 hosts 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 hosts 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 parametersendpoints
- 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
Hosts anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples
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 hosts 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 hosts 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 parametersendpoints
- 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
Hosts anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None