DysphagiaDYS-CBASNCT06618742
Focal Cryoballoon Ablation for Malignant Dysphagia
A study testing Cryotherapy in people with Dysphagia and Esophageal Cancer, run by Laura Boer at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Esophageal Cancer, Cryotherapy
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Alternative etiology for dysphagia
- Inability to pass the ultraslim endoscope
- Severe medical comorbidities precluding endoscopy
- Uncorrected coagulopathy
- Prior distal esophagectomy
- Previous esophageal varices
Show all 11Show fewer
- Expected survival \<6 weeks
- Prior radiotherapy for esophageal cancer
- T4b esophageal cancer
- Incapacitated subjects
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMCU
Utrecht
Laura S Boer, Degree of medicine, 0887550224, l.s.boer-17@umcutrecht.nl
About this study
Official title: Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
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.
Read more
Objective:
- To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed.
- 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
- Conditions
- Dysphagia, Esophageal Cancer, Cryotherapy
- Being tested
- Cryotherapy
- Keywords
- cryoballoon ablation
- Medical subject headings
- Deglutition Disorders, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Also called cryoballoon ablation
Focal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (6)
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)
Measured: 2 weeks
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.
Measured: 12 weeks
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
Measured: 2 weeks
secondary outcome safety
Incidence of all (S)AE's
Measured: 12 weeks
secondary outcome other palliation
Necessity of receiving any other kind of palliation for dysphagia during follow-up
Measured: 12 weeks
Secondary outcome immunology
(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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Jun 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Boer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Boer, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618742
- Sponsor's protocol ID
- NL84764.000.23
- Acronym
- DYS-CBAS
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06618742
- Acronym / sponsor ID
- DYS-CBAS / NL84764.000.23
- Conditions
- Dysphagia, Esophageal Cancer, Cryotherapy
- Keywords
- cryoballoon ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laura BoerUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Alternative etiology for dysphagia
- Inability to pass the ultraslim endoscope
- Severe medical comorbidities precluding endoscopy
- Uncorrected coagulopathy
- Prior distal esophagectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyAlso: cryoballoon ablationFocal cryoballoon ablation, 1-3 treatments with an interval of 1-3 weeks | Procedure or surgery | – |
Primary outcome
Primary outcome safety
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
secondary outcome efficacy subjective
Time frame: 2 weeks
secondary outcome efficacy subjective
Time frame: 12 weeks
secondary outcome pain
Time frame: 2 weeks
secondary outcome safety
Time frame: 12 weeks
secondary outcome other palliation
Time frame: 12 weeks
Secondary outcome immunology
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Dysphagia and Esophageal Cancer, run by Laura Boer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura S Boer, Degree of medicine (0887550224, l.s.boer-17@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome safety (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.