Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

NCT ID: NCT01360541

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-22
• Study Completion Date: 2018-12-14

Brief Summary

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

Conditions

Barrett Oesophagus; Low Grade Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency ablation

Endoscopic radiofrequency ablation of BE

Group Type: EXPERIMENTAL

Endoscopic radiofrequency ablation

Intervention Type: PROCEDURE

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

Surveillance

Endoscopic surveillance and PPI treatment

Group Type: ACTIVE_COMPARATOR

Endoscopic surveillance

Intervention Type: OTHER

Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Interventions

Endoscopic radiofrequency ablation

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

Intervention Type: PROCEDURE

Endoscopic surveillance

Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic PRAT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology and Endoscopy department, Cochin Hospital

Locations

Gastroenterology and Endoscopy department, Cochin Hospital

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33685969 (View on PubMed)

Other Identifiers

P081240

Identifier Type: -

Identifier Source: org_study_id