Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

NCT01360541 | Completed Phase 2

• 1 other identifier: P081240
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Conditions

Barrett Oesophagus; Low Grade Dysplasia

Keywords

Barrett oesophagus; Low grade dysplasia; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Prevalence of low grade dysplasia 3 years after randomization

  3 years after randomization

Secondary Outcomes (6)

• Prevalence of low grade dysplasia in each group

  1 and 5 years after randomization

• Rate of complete eradication of Barrett oesophagus

  1, 3 and 5 years after randomization

• Incidence of high grade dysplasia and adenocarcinoma

  3, 5 years after randomization

• Cost - efficacy comparison of the 2 strategies

  5 years

• Rate of complications in radiofrequency ablation group

  5 years after randomization

Study Arms (2)

Radiofrequency ablation

EXPERIMENTAL

Endoscopic radiofrequency ablation of BE

Procedure: Endoscopic radiofrequency ablation

Surveillance

ACTIVE COMPARATOR

Endoscopic surveillance and PPI treatment

Other: Endoscopic surveillance

Interventions

Endoscopic radiofrequency ablation 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

Radiofrequency ablation

Endoscopic surveillance OTHER

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

Surveillance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Gastroenterology and Endoscopy department, Cochin Hospital

Paris, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 33685969 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Frederic PRAT, MD, PhD

  Gastroenterology and Endoscopy department, Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: December 22, 2010
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)