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A Randomized Trial comparing Surveillance with Radio-Frequency Ablation of Barrett’s Esophagus with Low-Grade Dysplasia; the SURF-study.

ABSTRACT: Interventions: Radiofrequency ablation of the Barrett’s segment. Primary outcome(s): Rate of high-grade intraepithelial neoplasia and early cancer during two year follow-up. Study Design: Randomized controlled trial, Open (masking not used), Active, Parallel

DISEASE(S): The Most Important Risk Factor For Developing Esophageal Adenocarcinoma (eac) Is The Presence Of A Barrett Esophagus (be), A Condition In Which, Due To Chronic Gastro-esophageal Reflux, The Epithelium Of The Distal Esophagus Has Been Replaced By Columnar Epithelium Containing Specialized Intestinal Metaplasia. Patients With Low Grade Intraepithelial Neoplasia (lgin) Are Therefore Kept Under More Close Observation And/or Undergo More Frequent Endoscopic Surveillance (every 6 To 12 Months). Endoscopic Surveillance For Be Is Uncomfortable To The Patient And Cost-effectiveness Is Not Evidence-based

PROVIDER: 15583 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Circumferential radiofrequency ablation of Barrett’s esophagus with the Self-sizing RFA balloon. Inspection of the Barrett’s segment and randomization The esophagus is evaluated using white light high-resolution endoscopy (WLE) and narrow band imaging (NBI). The extent of columnar lined esophagus is documented according to the Prague C&M classification15 and by taking still images with WLE+NBI at 1 cm intervals. In the absence of visible abnormalities and no severe stenosis, patients are subsequently randomized to circumferential ablation with the Self Sizing RFA balloon using the simplified or the standard ablation regiment. Patients will be blinded for the administered treatment regimen. Standard ablation regimen After mapping and randomization, the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. The Self Sizing RFA balloon (GI Solutions Covidien, Sunnyvale, CA) is then introduced and positioned at the desired treatment zone. The device is inflated, and the electrode unfurls until the electrode contacts the esophageal wall. Under visual control the BE is ablated (12 J/cm2 at 300 Watt) working proximal to distal using visual repositioning. A small overlap (i.e. <1cm) between ablation zones is allowed. After the first ablation pass, the endoscope is removed followed by removal of the ablation catheter. The coagulum is cleaned off the balloon catheter. The endoscope is reintroduced to irrigate and suction the ablation zone. A distal attachment cap may be attached to the tip of the endoscope to gently wipe of the coagulum from the ablated segment. After irrigating and suctioning the debris away as much as possible, the Self Sizing RFA RCT November 2014 vs 1 Page 10 van 16 ablat Primary outcome: Percentage of endoscopically visual surface regression of BE epithelium at 3 months, as scored by two independent endoscopists blinded to the treatment regimen. Study Design: Randomized controlled trial, Double blinded (masking used), Active, Parallel

Dataset Information

A Randomized Trial comparing Surveillance with Radio-Frequency Ablation of Barrett’s Esophagus with Low-Grade Dysplasia; the SURF-study.

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