Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03621319
Status:
TERMINATED
Last Update Posted:
2021-07-06
First Post:
2018-07-19
Brief Title:
Eradicating Barretts Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique
Sponsor:
Erbe Elektromedizin GmbH
Organization:
Erbe Elektromedizin GmbH
Study Overview
Official Title:
Eradicating Barretts Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique BURN
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closure due to the COVID-19 pandemic Protocol specified procedures could not be followed resulting in unavoidable protocol deviations Lower enrollment than expected Competing COVID-19 studies at study sites No ethical scientific safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BURN
Brief Summary:
Lay summary Barretts Esophagus BE involves a change of the esophagus lining BE epithelium which in a small proportion of patients could be the starting point for the development of cancer esophageal adenocarcinoma Currently there is evidence that this change is initiated by acid reflux from the stomach which then could progress in a stepwise manner from the healthy epithelium to cellular changes intestinal metaplasia low-grade and high-grade dysplasia and finally to adenocarcinoma Surgery is considered the standard therapy for this cancer which involves the risk of death and complications with quality of life impairments New possibilities for treatment have evolved with endoscopic therapies which allow for treatment of early changes of the epithelium intestinal metaplasia and dysplasia prior to the occurrence of cancer using either argon plasma coagulation APC or radiofrequency ablation RFA Both are established methods for eradication of BE by thermal ablation of the BE epithelium using high frequency current HF More advanced BE epithelium with early visible cancers are being treated by endoscopic mucosal resection EMR After EMR the residual Barretts epithelium can also be removed by ablation with RFA or APC Currently radiofrequency ablation RFA has been suggested as the standard therapy for BE treatment Although effective in the eradication of the BE epithelium after RFA treatment the re-appearance of BE epithelium and the occurrence of complications such as strictures causing swallowing impairments for food have also been observed in clinical studies A recently developed method is Hybrid argon plasma coagulation ablation HybridAPC HAPC which combines argon plasma coagulation APC with a fluid injection function by a water beam The water beam allows to establish a fluid cushion normal sterile saline right beneath the BE-epithelium prior to thermal ablation thereby protecting the esophagus wall from heat during ablation of epithelium with APC The goal of this randomized controlled study is to investigate if HAPC is non-inferior to RFA in the stricture-free eradication of the dysplastic BE epithelium
Detailed Description:
Barretts Esophagus BE is a pre-malignant condition and may progress to low grade dysplasia high grade dysplasia and ultimately esophageal adenocarcinoma which has poor prognosis with a 5-year survival rate of only 5 - 20 Radiofrequency ablation RFA is a standard modality and well-studied endoscopic treatment for dysplastic BE HybridAPC HAPC is a newer technique for endoscopic treatment of dysplastic BE that involves submucosal fluid injection prior to performing APC The study aim of this non-inferiority study is to show that HAPC is at least as safe and effective as RFA in the stricture-free eradication of dysplasia CE-D
The study is a multi-center parallel group HAPCRFA prospective single blind non-inferiority randomized controlled study to assess the safety and effectiveness of HAPC treatment arm compared to RFA control arm in the treatment of BE in up to 144 male and female adult patients Participants of the study will be enrolled in up to 15 centers in the US Both techniques have never been directly compared in the treatment of BE
The specific aim of this non-inferiority study is to show that HAPC is at least as safe and effective as RFA in the stricture-free eradication of dysplasia CE-D by inducing complete eradication of dysplasia CE-D within 12 months after last treatment as confirmed by endoscopy and histology
HybridAPC is an endoscopic technique that is used with the HybridAPC Probe the Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator APC Model APC 2Electrosurgical Unit ESU VIO Model System The Water Jet delivers pressurized sterile 09 sodium chloride solution normal saline through the HybridAPC Probe into the submucosa of the Barrett mucosa Reductionlimitation of unwanted tissue damage penetration depth is being ensured by the saline cushion when applying argon plasma coagulation to ablate Barretts mucosa with subsequent regeneration of esophageal squamous mucosa
Radiofrequency ablation RFA applied in the control arm using BarrxTM FLEX RFA Generator is an endoscopic technique that delivers high radiofrequency waves using either circumferential balloon inserted over an endoscopically placed guidewire device of focal probe attached to the tip of the endoscope device to damage the Barretts mucosa with subsequent regeneration of esophageal squamous mucosa While a circumferential device can be used to treat larger BE areas focal device Halo 60 90 or through the scope device can be used to treat small islands of residual BE The depth of the injury is controlled by regular spacing of the electrodes and the delivery of a pre-set amount of energy through the probes The PICo-investigators will be instructed to operate the BarrxTM FLEX RFA Generator and above referenced catheters according to the cleared labeling
Patients with dysplastic BE will be identified at each participating center and defined as those with LGD within previous 6 months and HGDcancer within previous 6 months both timed from date of consent All histology slides from biopsies and endoscopic mucosal resection EMR specimens will be read by the local pathologist for patient management purposes and separately by a single independent reference pathologist to confirm patient eligibility for randomization
Eligible patients will be block randomized at each participating study center at a ratio of 1 1 to receive treatment of dysplasia with HAPC or RFA after EMR of visible lesions if present has been performed as per standard of care All patients will be assigned a unique registration number allocated by the Electronic Data Capture EDC system following details submitted on a web form Due to the nature of the intervention only the patient will be blinded single blinding and not the PI or Co-investigators The assigned HAPC ablation or RFA procedure will be performed at 8 to 12-week intervals until eradication of BE has been achieved A maximum number of 4 treatment sessions is allowed
Once the BE has been eradicated endoscopically 4 quadrant biopsies every 1-2 cm will be performed to confirm complete eradication of dysplasiaIM standard of care and slides sent for confirmation by the central pathologist
Primary statistical analysis will compare the proportions of patients in whom stricture-free eradication of dysplastic BE has been achieved
As secondary endpoints complete endoscopic and histological eradication of intestinal metaplasia CE-IM stricture rate post-operative pain cost-effectiveness and recurrence of intestinal metaplasia and dysplasia will be documented and reported No formal tests of hypothesis will be applied for these secondary endpoints
Data from the trial will be entered into a database VISION EDC version 8 Prelude Dynamics Austin TX and all statistical analyses will be performed using validated software SAS version 94 IBMSPSS version 23 Cytel StatXact version 11 or R
The study is a multi-center parallel group HAPCRFA prospective single blind non-inferiority randomized controlled study to assess the safety and effectiveness of HAPC treatment arm compared to RFA control arm in the treatment of BE in up to 144 male and female adult patients Participants of the study will be enrolled in up to 15 centers in the US Both techniques have never been directly compared in the treatment of BE
The specific aim of this non-inferiority study is to show that HAPC is at least as safe and effective as RFA in the stricture-free eradication of dysplasia CE-D by inducing complete eradication of dysplasia CE-D within 12 months after last treatment as confirmed by endoscopy and histology
HybridAPC is an endoscopic technique that is used with the HybridAPC Probe the Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator APC Model APC 2Electrosurgical Unit ESU VIO Model System The Water Jet delivers pressurized sterile 09 sodium chloride solution normal saline through the HybridAPC Probe into the submucosa of the Barrett mucosa Reductionlimitation of unwanted tissue damage penetration depth is being ensured by the saline cushion when applying argon plasma coagulation to ablate Barretts mucosa with subsequent regeneration of esophageal squamous mucosa
Radiofrequency ablation RFA applied in the control arm using BarrxTM FLEX RFA Generator is an endoscopic technique that delivers high radiofrequency waves using either circumferential balloon inserted over an endoscopically placed guidewire device of focal probe attached to the tip of the endoscope device to damage the Barretts mucosa with subsequent regeneration of esophageal squamous mucosa While a circumferential device can be used to treat larger BE areas focal device Halo 60 90 or through the scope device can be used to treat small islands of residual BE The depth of the injury is controlled by regular spacing of the electrodes and the delivery of a pre-set amount of energy through the probes The PICo-investigators will be instructed to operate the BarrxTM FLEX RFA Generator and above referenced catheters according to the cleared labeling
Patients with dysplastic BE will be identified at each participating center and defined as those with LGD within previous 6 months and HGDcancer within previous 6 months both timed from date of consent All histology slides from biopsies and endoscopic mucosal resection EMR specimens will be read by the local pathologist for patient management purposes and separately by a single independent reference pathologist to confirm patient eligibility for randomization
Eligible patients will be block randomized at each participating study center at a ratio of 1 1 to receive treatment of dysplasia with HAPC or RFA after EMR of visible lesions if present has been performed as per standard of care All patients will be assigned a unique registration number allocated by the Electronic Data Capture EDC system following details submitted on a web form Due to the nature of the intervention only the patient will be blinded single blinding and not the PI or Co-investigators The assigned HAPC ablation or RFA procedure will be performed at 8 to 12-week intervals until eradication of BE has been achieved A maximum number of 4 treatment sessions is allowed
Once the BE has been eradicated endoscopically 4 quadrant biopsies every 1-2 cm will be performed to confirm complete eradication of dysplasiaIM standard of care and slides sent for confirmation by the central pathologist
Primary statistical analysis will compare the proportions of patients in whom stricture-free eradication of dysplastic BE has been achieved
As secondary endpoints complete endoscopic and histological eradication of intestinal metaplasia CE-IM stricture rate post-operative pain cost-effectiveness and recurrence of intestinal metaplasia and dysplasia will be documented and reported No formal tests of hypothesis will be applied for these secondary endpoints
Data from the trial will be entered into a database VISION EDC version 8 Prelude Dynamics Austin TX and all statistical analyses will be performed using validated software SAS version 94 IBMSPSS version 23 Cytel StatXact version 11 or R
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None