Improving practicality of radiofrequency ablation for eradication of Barrett’s mucosa: A randomized trial comparing three different treatment regimens for circumferential ablation using the HALO360 System.

ABSTRACT: Interventions: Circumferential balloon-based endoscopic radiofrequency ablation using the HALO system for Barrett’s early neoplasia. These treatment sessions take approximally 30-60 minutes. Treatment protocol: HALO360 procedure: The esophagus is evaluated using white light (WL) high-resolution endoscopy and narrow band imaging (NBI). The extent of columnar lined esophagus is documented according to the Prague C&M classification and the number and localization of islands of Barrett’s are noted. A pullback video recording (WL+NBI) of the Barrett’s segment is obtained. If this is not possible, still images (WL+NBI) for every cm of the BE while pulling back from the top of the gastric folds (TGF). Patients are subsequently randomized to circumferential ablation with the HALO360 system using the simplified or the standard ablation regimen. Standard HALO360 ablation regimen: After mapping and randomization, the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. Subsequently, a guide wire is inserted into the duodenum and the endoscope is removed. A non-compliant sizing balloon (BÂRRX Medical, Sunnyvale, CA) is then introduced over the guide wire and positioned 4 cm above the proximal margin of BE. The balloon is then automatically inflated to 4 psi (0.28 atm) and the internal esophageal diameter is automatically calculated based on baseline balloon volume/geometry and the inflated pressure/volume. Sizing is repeated moving distally, for every 1 cm of BE until the transition to cardia is detected by a rapid increase in calculated diameter. After previous ER, the advice is to use an ablation catheter that is one step smaller in diameter than the diameter advised by the sizing Primary outcome(s): Percentage of endoscopically visual surface regression of BE epithelium at 3 months as scored by two endoscopists blinded to the treatment regimen by using endoscopic images of the Barrett’s esophagus prior to and 3 months after the the first treatment session (e.g. 80% of the Barrett’s epithelium in regression). And, by using standardized case record forms on which the size and aspect of the Barrett’s esophagis prior to and after the first treatment session are registered. Study Design: Randomized controlled trial, Double blinded (masking used), Active, Parallel

DISEASE(S): Intestinal Metaplasia,Barrett's Esophagus,Radiofrequency Ablation,Barrett's Dysplasia,Intraepithelial Neoplasia,Endoscopy,Early Barrett's Neoplasia

PROVIDER: 16795 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR