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

Primary Purpose

Barrett Oesophagus, Low Grade Dysplasia

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Endoscopic radiofrequency ablation

Endoscopic surveillance

About this trial

This is an interventional treatment trial for Barrett Oesophagus focused on measuring Barrett oesophagus, Low grade dysplasia, Radiofrequency ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gastroenterology and Endoscopy department, Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiofrequency ablation

Surveillance

Arm Description

Endoscopic radiofrequency ablation of BE

Endoscopic surveillance and PPI treatment

Outcomes

Primary Outcome Measures

Prevalence of low grade dysplasia 3 years after randomization

Secondary Outcome Measures

Prevalence of low grade dysplasia in each group

Rate of complete eradication of Barrett oesophagus

Incidence of high grade dysplasia and adenocarcinoma

Cost - efficacy comparison of the 2 strategies

Rate of complications in radiofrequency ablation group

Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique

Full Information

NCT ID

NCT01360541

First Posted

May 24, 2011

Last Updated

April 16, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01360541

Brief Title

Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Acronym

RF-DBG

Official Title

Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 22, 2010 (Actual)

Primary Completion Date

December 14, 2018 (Actual)

Study Completion Date

December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett Oesophagus, Low Grade Dysplasia

Keywords

Barrett oesophagus, Low grade dysplasia, Radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiofrequency ablation

Arm Type

Experimental

Arm Description

Endoscopic radiofrequency ablation of BE

Arm Title

Surveillance

Arm Type

Active Comparator

Arm Description

Endoscopic surveillance and PPI treatment

Intervention Type

Procedure

Intervention Name(s)

Endoscopic radiofrequency ablation

Intervention Description

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

Other

Intervention Name(s)

Endoscopic surveillance

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevalence of low grade dysplasia 3 years after randomization

Time Frame

3 years after randomization

Secondary Outcome Measure Information:

Title

Prevalence of low grade dysplasia in each group

Time Frame

1 and 5 years after randomization

Title

Rate of complete eradication of Barrett oesophagus

Time Frame

1, 3 and 5 years after randomization

Title

Incidence of high grade dysplasia and adenocarcinoma

Time Frame

3, 5 years after randomization

Title

Cost - efficacy comparison of the 2 strategies

Time Frame

5 years

Title

Rate of complications in radiofrequency ablation group

Time Frame

5 years after randomization

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic PRAT, MD, PhD

Organizational Affiliation

Gastroenterology and Endoscopy department, Cochin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastroenterology and Endoscopy department, Cochin Hospital

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

33685969

Citation

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.

Results Reference

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Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

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