Barrett EsophagusRATENCT05051475
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus
A study testing Endoscopic radiofrequency ablation and Endoscopic hybrid argon plasma coagulation in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease
- What is being tested?
- Endoscopic radiofrequency ablation and Endoscopic hybrid argon plasma coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 5 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects over 18 years
- Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
- General health status sufficient to perform an endoscopic procedure (ASA I-III)
Who cannot join
- Primary or secondary coagulopathy, with INR>1.5 and/or platelet count of <75,000.
- Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
- Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
- Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
- Any history of esophageal resection surgery
- Esophageal varices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)
This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.
Read the detailed description
Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease
- Being tested
- Endoscopic radiofrequency ablation, Endoscopic hybrid argon plasma coagulation
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic radiofrequency ablationProcedure or surgery
Endoscopic ablation technique for Barrett's epithelium
Endoscopic hybrid argon plasma coagulationProcedure or surgery
Endoscopic ablation technique for Barrett's epithelium
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency ablation | Active comparator | Circumferential ablation with radiofrequency ablation will be performed for each segment of the BE starting from the proximal end with one ablation at 12J/cm2, followed by cleaning of mucosal slough with esophageal cap, patient extubation, cleaning of ablation device with wet gauze, and finally a second ablation at 12 J/cm2 (1 × 12J/cm2-clean-1 × 12 J/cm2). Focal ablations will be performed with three consecutive ablations at 12 J/cm2 without cleaning (simplified protocol). Receives: Procedure: Endoscopic radiofrequency ablation |
| hybrid argon plasma coagulation | Active comparator | Patients in the Hybrid argon plasma coagulation group will be treated with a single ablation per session with a power limitation of 60 W (pulsed mode (VIO® 300 D \& APC 2, PULSED APC®, Effect 2). No scraping with the endoscope cap and second ablation will be performed. Receives: Procedure: Endoscopic hybrid argon plasma coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of post-procedural pain
Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure.
Measured: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.
Level of post-procedural pain at day 7 after treatment
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Measured: Measured at day 7 after the procedure
Level of late post-procedural pain (at day 30 after treatment)
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Measured: Measured at day 30 after the procedure
Secondary outcomes (3)
Level of post-procedural dysphagia
Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia)
Measured: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
Level of post-procedural quality of life
Evaluated by the QLQ-OES18 questionnaire specific for esophageal symptoms, and consists of a symptom scale only. The QLQ-OES18 includes 18 questions: 6 single item subscales relating to saliva swallowing, choking, dry mouth, taste, coughing, and talking. It also includes 12 items grouped into 4 subscales: dysphagia (3 items), eating (4 items), reflux (2 items), and pain (3 items).
Measured: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
The rate of complications
Intra-procedural complications, such as bleeding, perforation, post-procedural complications, e.g. chest-pain, esophageal stricture will be monitored during the hospital stay and follow-up at day 7 and day 30 after the procedure (phone call).
Measured: Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Dec 2021
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
- Responsible party
- Sponsor
- Investigators
- Wladyslaw Januszewicz, MD, Principal investigator, Centre for Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051475
- Sponsor's protocol ID
- 2021
- Acronym
- RATE
- Status last verified
- May 2025
- First submitted
- 2 Sep 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)
- ClinicalTrials.gov ID
- NCT05051475
- Acronym / sponsor ID
- RATE / 2021
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncology
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 21 Sep 2021 (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.
This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.
Detailed description
Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency ablation | Active comparator | Procedure: Endoscopic radiofrequency ablationCircumferential ablation with radiofrequency ablation will be performed for each segment of the BE starting from the proximal end with one ablation at 12J/cm2, followed by cleaning of mucosal slough with esophageal cap, patient extubation, cleaning of ablation device with wet gauze, and finally a second ablation at 12 J/cm2 (1 × 12J/cm2-clean-1 × 12 J/cm2). Focal ablations will be performed with three consecutive ablations at 12 J/cm2 without cleaning (simplified protocol). |
| hybrid argon plasma coagulation | Active comparator | Procedure: Endoscopic hybrid argon plasma coagulationPatients in the Hybrid argon plasma coagulation group will be treated with a single ablation per session with a power limitation of 60 W (pulsed mode (VIO® 300 D \& APC 2, PULSED APC®, Effect 2). No scraping with the endoscope cap and second ablation will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects over 18 years
- Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
- General health status sufficient to perform an endoscopic procedure (ASA I-III)
Key exclusion criteria (6 listed)
- Primary or secondary coagulopathy, with INR>1.5 and/or platelet count of <75,000.
- Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
- Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
- Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
- Any history of esophageal resection surgery
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 |
|---|---|---|
| Endoscopic radiofrequency ablationEndoscopic ablation technique for Barrett's epithelium | Procedure or surgery | radiofrequency ablation |
| Endoscopic hybrid argon plasma coagulationEndoscopic ablation technique for Barrett's epithelium | Procedure or surgery | hybrid argon plasma coagulation |
Primary outcome
Level of post-procedural pain
Time frame: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.
Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure.
Level of post-procedural pain at day 7 after treatment
Time frame: Measured at day 7 after the procedure
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Level of late post-procedural pain (at day 30 after treatment)
Time frame: Measured at day 30 after the procedure
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
3 secondary outcomes
Level of post-procedural dysphagia
Time frame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
Level of post-procedural quality of life
Time frame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
The rate of complications
Time frame: Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Barrett Esophagus
RecruitingObservational study
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Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
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Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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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.
Wladyslaw Januszewicz, MD principal investigator
Centre for Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic radiofrequency ablation and Endoscopic hybrid argon plasma coagulation in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Oct 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of post-procedural pain (time frame: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.). 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 3 Oct 2025.