Bristol Royal Infirmary M.Boal, D. Titcomb 2/2/17 Radiofrequency ablation (HALO) in the treatment of Oesophageal Dysplasia Bristol Royal Infirmary M.Boal, D. Titcomb 2/2/17

Background 5-13% patients with GORD develop Barrett’s Oesophagus (BO) 64-86% oesophageal adenocarcinoma (OAC) develops in BO, with BO having 11 fold increase risk of developing OAC Radiofrequency ablation (RFA) is a minimally invasive endoscopic technique to prevent progression of disease requiring oesophagectomy

Background RFA applies bipolar energy to the oesophageal mucosa causing coagulative necrosis , eradicating: BO in 66-100% of cases Dysplastic BO in 79-100% T1a (early mucosal cancer) in 81-92% Sizing A catheter is inserted into the Oesophagus along side the endoscope At the tip of the catheter there is a small balloon that is inflated once inside your Oesophagus near the treatment area. The balloon and the HALOFLEX Energy Generator together measure the diameter of the Oesophagus. This information is used by the physician to select the appropriate treatment catheter. The sizing balloon is then removed and the treatment and the HALO360+ Ablation Catheter is introduced. Ablation The HALO360+ Ablation Catheter also has a balloon at the tip, but this balloon is covered by a band of radio frequency electrodes. Once the electrodes of the balloon are positioned on the desired treatment area the balloon is inflated. The HALO360 Energy Generator and the ablation catheter then work together to deliver a short burst of energy that is circumferential: 360 degrees. Once the electrodes of the balloon are positioned on the desired treatment area the balloon is inflated. The HALO360 Energy Generator and the ablation catheter then work together to deliver a short burst of energy that is circumferential: 360 degrees. The design of this technology limits the energy delivery to a depth clinically proven to remove the diseased tissue while reducing the risk of injury to the deeper and healthy tissue layers. The HALO360+ Ablation Catheter ablates a 3cm circumferential segment of Barrett's tissue within the oesophagus For patients with Barrett's Oesophagus lesions longer than 3cm, the HALO360+ Ablation Catheter is simply repositioned and the ablation steps are repeated.

NICE guidance 2010: Recommend use in dysplastic BO Use in non-dysplastic BO and squamous dysplasia for research purposes 2014: Enough evidence for use in low grade dysplasia (LGD)

The British Society of Gastroenterologists guidance RFA is preferred to oesophagectomy or surveillance in high grade dysplasia (HGD) and Barrett’s related OAC confined to mucosa (Grade B recommendation) Post EMR visible flat lesions should be managed with RFA (Grade A recommendation) Follow up endoscopy

NOGCA Despite The BSG/ NICE recommendation that RFA should be offered to patients with HGD, Tis/T1a disease, NOGCA data suggests 29.7% are still offered surveillance.

Aim: Rates of dysplasia progression and regression for patients who underwent radiofrequency ablation (HALO/Barrx-Flex)

Primary outcome: Assess rates of disease regression post index RFA intervention Secondary: Assess rates of disease progression post RFA intervention and complication

Method: Single centre Retrospective data extracted from clinical/electronic notes 1st data set June 2011- Oct 2014 2nd data set Nov 2014-Dec 2016 Cx: 4 strictures & one oesophagitis leading to poor oral intake and AKI, one ulcer

Median interval index to 1st procedure biopsy (range) Results: 1st data 6/2011-10/2014 2nd data 11/2014-12/2016 Total Patients (n) 31 28 59 BO patients 25 27 52 Squamous dysplasia 6 1 7 Median age (range) 73 years (54-91) 67 years (51-85) 70 years Median interval index to 1st procedure biopsy (range) 64 days (38-443) 66 day (37-405) 65 days

Results Active follow up n=48 Active follow up n=7 n=7 At one year: Static Progression Regression 7/48 (15%) 3/48 (6%) 38/48 (79%) Active follow up n=7 n=7 2/7 (29%) 3/7 (42%) At one year: DB: Static 2/32 (6.5%), Progression 3/32 (9.5%), Regression 27/32 (84%) Not all were followed up in BRI or were discharged

Conclusion RFA is less invasive and cost effective compared to alternative treatment (surgery) and is associated with less morbidity and no mortality RFA is effective, causing disease regression in most cases. RFA may halt or slow progression