Focal Cryoballoon Ablation for Malignant Dysphagia

NCT06618742 | Recruiting

• 1 other identifier: NL84764.000.23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• \- 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

Conditions

Dysphagia; Esophageal Cancer; Cryotherapy

Keywords

cryoballoon ablation

Outcome Measures

Primary Outcomes (3)

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  1 day

Secondary Outcomes (6)

• secondary outcome efficacy subjective

  2 weeks

• secondary outcome efficacy subjective

  12 weeks

• secondary outcome pain

  2 weeks

• secondary outcome safety

  12 weeks

• secondary outcome other palliation

  12 weeks

Interventions

Cryotherapy PROCEDURE

Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks

Also known as: cryoballoon ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Boer: lead

Study Sites (1)

UMCU

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Laura S Boer, Degree of medicine

CONTACT

0887550224; l.s.boer-17@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: June 24, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

NL (1)