Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia (RF-DBG)

This study is currently recruiting participants.
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01360541
First received: May 24, 2011
Last updated: July 26, 2013
Last verified: July 2013

May 24, 2011
July 26, 2013
December 2010
June 2018   (final data collection date for primary outcome measure)
Prevalence of low grade dysplasia 3 years after randomization [ Time Frame: 3 years after randomization ] [ Designated as safety issue: No ]
Prevalence of low grade dysplasia 3 years after inclusion [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01360541 on ClinicalTrials.gov Archive Site
  • Prevalence of low grade dysplasia in each group [ Time Frame: 1 and 5 years after randomization ] [ Designated as safety issue: No ]
  • Rate of complete eradication of Barrett oesophagus [ Time Frame: 1, 3 and 5 years after randomization ] [ Designated as safety issue: No ]
  • Incidence of high grade dysplasia and adenocarcinoma [ Time Frame: 3, 5 years after randomization ] [ Designated as safety issue: No ]
  • Cost - efficacy comparison of the 2 strategies [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Rate of complications in radiofrequency ablation group [ Time Frame: 5 years after randomization ] [ Designated as safety issue: Yes ]
  • Prevalence of low grade dysplasia in each group [ Time Frame: 1 and 5 years after inclusion ] [ Designated as safety issue: No ]
  • Rate of complete eradication of Barrett oesophagus [ Time Frame: 1, 3 and 5 years ] [ Designated as safety issue: No ]
  • Incidence of high grade dysplasia and adenocarcinoma [ Time Frame: 3, 5 years ] [ Designated as safety issue: No ]
  • Cost - efficacy comparison of the 2 strategies [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Rate of complications in radiofrequency ablation group [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Barrett Oesophagus
  • Low Grade Dysplasia
  • Procedure: 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
    Other Name: Endoscopic radiofrequency ablation
  • Other: Endoscopic surveillance
    Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.
    Other Name: Endoscopic surveillance
  • Experimental: Radiofrequency ablation
    Endoscopic radiofrequency ablation of BE
    Intervention: Procedure: Endoscopic radiofrequency ablation
  • Active Comparator: Surveillance
    Endoscopic surveillance and PPI treatment
    Intervention: Other: Endoscopic surveillance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2018
June 2018   (final data collection date for primary outcome measure)

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)
  • 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)
  • Life expectancy < 2 years
  • Disability to take PPI oral medication or follow the protocol surveillance schedule
Both
18 Years to 80 Years
No
Contact: Frederic PRAT, MD, PhD +33 (0)1 58 41 19 45 frederic.prat@cch.aphp.fr
Contact: Raphaël SERREAU, MD, PhD +33 (0) 1 58 41 11 80 raphael.serreau@cch.aphp.fr
France
 
NCT01360541
P081240
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Frederic PRAT, MD, PhD Gastroenterology and Endoscopy department, Cochin Hospital
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP