Barrett OesophagusPhase 2RF-DBGNCT01360541
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia
A Phase 2 study testing Endoscopic radiofrequency ablation and Endoscopic surveillance in people with Barrett Oesophagus and Low Grade Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Oesophagus, Low Grade Dysplasia
- What is being tested?
- Endoscopic radiofrequency ablation and Endoscopic surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2010to 14 Dec 2018
- Phase
- Phase 2
- 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
- BE with certain LGD in at least one endoscopic biopsy sample
- BE with maximal length of 12cm (Prague classification ≤ C12)
- BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3)
- Patients aged between 18 and 80 years
- Patients' consent for study enrollment
- No contra-indications to general anaesthesia
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- Patients ability to take PPI oral medication
- Patient affiliated to a social security system
- No pregnancy and active contraceptions for women in age to procreate
- In case of previous endoscopic mucosal resection for HGD in BE: at least one year of surveillance and 2 biopsy series with LGD without HGD
Who cannot join
- BE length > 12cm or < 1cm circumferentially (< C1) or < 3cm focally (<M3)
- HGD or adenocarcinoma needing a specific endoscopic or surgical treatment
- Active peptic oesophagitis (Savary III or IV)
- Presence of surgical staples on the area to be treated
- Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus
- previous oesophagus cancer
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- previous endoscopic destruction treatment such as photodynamic therapy or plasma argon coagulation
- previous Heller surgery
- oesophagus stenosis
- oesophagus varices
- oesophagus pathology associated with sclerodermia
- Severe coagulation disorders or thrombopenia
- Anaesthesia contra-indications (ASA 4)
- Hypersensitivity to fluorescein or any component of the fluorescein
- Life expectancy < 2 years
- Disability to take PPI oral medication or follow the protocol surveillance Schedule
Trial locations and contacts
1 site in 1 country.
France1 site
Gastroenterology and Endoscopy department, Cochin Hospital
Paris, 75014
About this study
Official title: Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
Read the detailed description
Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.
Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.
Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.
120 patients are planned to be included for at least 40 patients randomized in each group.
Primary endpoint: Prevalence of LGD in each group 3 years after randomization
Secondary endpoints:
- Prevalence of LGD in each group 1 and 5 years after randomization
- Rate of complete eradication of BE at 1, 3 and 5 years after randomization
- Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
- Rate of complications in RFA group after randomization
- Cost - efficacy comparison of the 2 strategies
- Conditions
- Barrett Oesophagus, Low Grade Dysplasia
- Being tested
- Endoscopic radiofrequency ablation, Endoscopic surveillance
- Keywords
- Barrett oesophagus, Low grade dysplasia, Radiofrequency ablation
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic radiofrequency ablationProcedure or surgery
HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W
Endoscopic surveillanceOther
Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | Endoscopic radiofrequency ablation of BE Receives: Procedure: Endoscopic radiofrequency ablation |
| Surveillance | Active comparator | Endoscopic surveillance and PPI treatment Receives: Other: Endoscopic surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of low grade dysplasia 3 years after randomization
Measured: 3 years after randomization
Secondary outcomes (6)
Prevalence of low grade dysplasia in each group
Measured: 1 and 5 years after randomization
Rate of complete eradication of Barrett oesophagus
Measured: 1, 3 and 5 years after randomization
Incidence of high grade dysplasia and adenocarcinoma
Measured: 3, 5 years after randomization
Cost - efficacy comparison of the 2 strategies
Measured: 5 years
Rate of complications in radiofrequency ablation group
Measured: 5 years after randomization
Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique
Measured: before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study start22 Dec 2010
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett OesophagusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Frederic PRAT, MD, PhD, Principal investigator, Gastroenterology and Endoscopy department, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360541
- Sponsor's protocol ID
- P081240
- Acronym
- RF-DBG
- Status last verified
- Sep 2025
- First submitted
- 24 May 2011
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.
PubMed 33685969
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
- ClinicalTrials.gov ID
- NCT01360541
- Acronym / sponsor ID
- RF-DBG / P081240
- Conditions
- Barrett Oesophagus, Low Grade Dysplasia
- Keywords
- Barrett oesophagus, Low grade dysplasia, Radiofrequency ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 22 Dec 2010 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 25 May 2011 (estimated)
- 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.
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
Detailed description
Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.
Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.
Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.
120 patients are planned to be included for at least 40 patients randomized in each group.
Primary endpoint: Prevalence of LGD in each group 3 years after randomization
Secondary endpoints:
- Prevalence of LGD in each group 1 and 5 years after randomization
- Rate of complete eradication of BE at 1, 3 and 5 years after randomization
- Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
- Rate of complications in RFA group after randomization
- Cost - efficacy comparison of the 2 strategies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Procedure: Endoscopic radiofrequency ablationEndoscopic radiofrequency ablation of BE |
| Surveillance | Active comparator | Other: Endoscopic surveillanceEndoscopic surveillance and PPI treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- BE with certain LGD in at least one endoscopic biopsy sample
- BE with maximal length of 12cm (Prague classification ≤ C12)
- BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3)
- Patients aged between 18 and 80 years
- Patients' consent for study enrollment
Key exclusion criteria (16 listed)
- BE length > 12cm or < 1cm circumferentially (< C1) or < 3cm focally (<M3)
- HGD or adenocarcinoma needing a specific endoscopic or surgical treatment
- Active peptic oesophagitis (Savary III or IV)
- Presence of surgical staples on the area to be treated
- Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus
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 ablationHALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W | Procedure or surgery | Radiofrequency ablation |
| Endoscopic surveillanceUpper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples. | Other | Surveillance |
Primary outcome
Prevalence of low grade dysplasia 3 years after randomization
Time frame: 3 years after randomization
6 secondary outcomes
Prevalence of low grade dysplasia in each group
Time frame: 1 and 5 years after randomization
Rate of complete eradication of Barrett oesophagus
Time frame: 1, 3 and 5 years after randomization
Incidence of high grade dysplasia and adenocarcinoma
Time frame: 3, 5 years after randomization
Cost - efficacy comparison of the 2 strategies
Time frame: 5 years
Rate of complications in radiofrequency ablation group
Time frame: 5 years after randomization
Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique
Time frame: before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)
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 12 Sep 2025.
- Results publication: PubMed 33685969Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.
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.
Frederic PRAT, MD, PhD principal investigator
Gastroenterology and Endoscopy department, Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endoscopic radiofrequency ablation and Endoscopic surveillance in people with Barrett Oesophagus and Low Grade Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 16 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 12 Sep 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of low grade dysplasia 3 years after randomization (time frame: 3 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01360541, which also lists 1 linked publication.
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 12 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.