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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Barrett Oesophagus
Low Grade Dysplasia
Procedure: Endoscopic radiofrequency ablation
Other: Endoscopic surveillance
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Prevalence of low grade dysplasia 3 years after randomization [ Time Frame: 3 years after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiofrequency ablation
Endoscopic radiofrequency ablation of BE
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
Active Comparator: Surveillance
Endoscopic surveillance and PPI treatment
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360541

Contacts
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

Locations
France
Gastroenterology and Endoscopy department, Cochin Hospital Recruiting
Paris, France, 75014
Contact: Frederic PRAT, MD, PhD    ++33158411945    frederic.prat@cch.aphp.fr   
Principal Investigator: Frederic Prat, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frederic PRAT, MD, PhD Gastroenterology and Endoscopy department, Cochin Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01360541     History of Changes
Other Study ID Numbers: P081240
Study First Received: May 24, 2011
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Barrett oesophagus
Low grade dysplasia
Radiofrequency ablation

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 20, 2014