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

April 16, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Gastroenterology and Endoscopy department, Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of low grade dysplasia 3 years after randomization
Time Frame: 3 years after randomization
3 years after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of low grade dysplasia in each group
Time Frame: 1 and 5 years after randomization
1 and 5 years after randomization
Rate of complete eradication of Barrett oesophagus
Time Frame: 1, 3 and 5 years after randomization
1, 3 and 5 years after randomization
Incidence of high grade dysplasia and adenocarcinoma
Time Frame: 3, 5 years after randomization
3, 5 years after randomization
Cost - efficacy comparison of the 2 strategies
Time Frame: 5 years
5 years
Rate of complications in radiofrequency ablation group
Time Frame: 5 years after randomization
5 years after randomization
Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique
Time Frame: before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)
before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Frederic PRAT, MD, PhD, Gastroenterology and Endoscopy department, Cochin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2010

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

December 14, 2018

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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