Dataset Information

Improving practicality of radiofrequency ablation for eradication of Barrett’s mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.

ABSTRACT: Interventions: Focal endoscopic radiofrequency ablation using the HALO90-catheter of the HALO System: Standard or simplified regimen: Prior to ablation the exact location of islands were registered: Distance to biteblock (cm) and the o’clock position, to by able to relocalize the treatment zone at follow-up endoscopy after 2 months. Standard regimen: After mapping and randomization the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. The endoscope is removed and the proximal esophagus is thoroughly inspected to exclude the presence of a Zenker’s diverticulum that may make subsequent introduction of the HALO90 cap difficult or dangerous. The HALO90 cap is attached to the tip of the endoscope at the twelve o’clock position and introduced into the distal esophagus. Visible islands are then treated with 2x15 J/cm2 (40 Watt)): the cap is brought into close contact with the target area and is then activated. The endoscope and the cap are kept in position and immediately a second ablation of the same area is performed. After ablation of an island, the endoscope is gently removed from the mucosa and rotated to remove the coagulum by suctioning through the endoscope. If the squamocolumnar junction (SQJ) has an irregular appearance the SQJ is treated circumferentially, allowing an overlap of 5-10 mm between the adjacent ablations. After all islands and Z-line have been ablated in this manner, the necrotic debris is cleaned off by a combination of suctioning and irrigating tap water. In addition, the HALO90 cap can be used to gently push off the coagulum from the ablation zone. Subsequently, the ablated areas are cleaned by vigorous flushing of water through a spraying catheter. After emptying Primary outcome(s): Rate of complete removal of BE islets (completely remove yes/no), as scored by the endoscopist (blinded for the allocation of the islands but nor the location of the islands that were randomized and treated) after 2 months as scored during the endoscopy using a standard case record form. Study Design: Randomized controlled trial, Double blinded (masking used), Active, Parallel

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

PROVIDER: 16809 | 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

Project description: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

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Improving practicality of radiofrequency ablation for eradication of Barrett’s mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.

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