Clinical trial · Interventional
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia
Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
NCT01360541CI-TRIAL-00094999RF-DBGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Oesophagus | — | UNRESOLVED | — |
| Low Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic radiofrequency ablation | Procedure | — | UNRESOLVED |
| Endoscopic surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation
- description
- Endoscopic radiofrequency ablation of BE
- interventionNames
- Procedure: Endoscopic radiofrequency ablation
- type
- ACTIVE_COMPARATOR
- label
- Surveillance
- description
- Endoscopic surveillance and PPI treatment
- interventionNames
- Other: Endoscopic surveillance
Primary outcomes (1)
- measure
- Prevalence of low grade dysplasia 3 years after randomization
- timeFrame
- 3 years after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- RESULTBarret 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. PMID 33685969