Focal Cryoballoon Ablation for Malignant Dysphagia

Not Applicable

Recruiting

• Conditions: Dysphagia; Esophageal Cancer; Cryotherapy

• Registration Number: NCT06618742
• Lead Sponsor: Laura Boer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Status Verified: 2024-09
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary outcome safety	2 weeks	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.
primary outcome efficacy	2 weeks	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.
primary outcome feasibility	1 day	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.

Secondary Outcome Measures

Name	Time	Method
secondary outcome efficacy subjective	12 weeks	Reported outcomes on dysphagia scores twice weekly, up to two weeks after endoscopy, and thereafter at week 6, 8 and 12.
secondary outcome pain	2 weeks	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
secondary outcome safety	12 weeks	Incidence of all (S)AE's
secondary outcome other palliation	12 weeks	Necessity of receiving any other kind of palliation for dysphagia during follow-up
Secondary outcome immunology	12 weeks	(Changes in) Host's anti-tumor response after cryoballoon ablation compared to baseline. Analyses on both blood and tissue samples will be performed. Moreover, the peripheral immune response will be compared with the tissue immune response.

Trial Locations

Locations (1)

UMCU; 🇳🇱 Utrecht, Netherlands