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. 2019 Aug 14;11(4):259–271. doi: 10.1136/flgastro-2019-101247

Table 4.

Appropriate intraprocedure (ablation) QIs after round 2 voting with the median score, MAD-M, BIOMED analysis, p value, IPRAS analysis and the performance threshold

Intraprocedure QIs (ablation) Median score MAD-M BIOMED analysis P value IPRAS analysis Performance threshold, median % (range)
Low-grade and high-grade dysplasia without visible lesions should undergo endoscopic ablation. 9 0.4 No disagreement 1 No disagreement 95 (80–100)
Aspirational performance target: 95% (range: 80–100).
Evidence summary:
The multicentre EURO II study showed that RFA can achieve CR-D and CR-IM rates of 92% and 87%, respectively,21 in patients with early BE neoplasia. A systematic review by Desai et al 22 also showed that ET of BE neoplasia with resection of visible lesions followed by ablation of the remaining segment of BE can achieve CR-D rate of 93.4% and CR-IM rate of 73.1%. ET for early BE neoplasia should therefore be offered after appropriate discussion with the patient as ET is associated with high rates of CR-D and CR-IM and reduction in disease progression and development of cancer. The efficacy and safety profile of RFA suggests that it is the best ablative modality currently available for patients with LGD and HGD without visible lesions. The diagnosis of dysplasia should be reproduced and confirmed by expert BE pathologists prior to consideration for EET. Recent meta-analysis by Qumseya et al studied the progression rates in patients with LGD based on review by an expert GI pathologist. The group was able to show that the rate of progression from LGD to HGD/OAC was significantly higher among studies where expert GI pathologist confirmed the diagnosis of LGD compared with studies that did not use a GI pathologist.23
Following endoscopic resection, patients undergo ablative therapy every 2–4 months in order to achieve CR-IM. 9 0.3 No disagreement 1 No disagreement 90 (80–100)
Aspirational performance target: 90% (range: 80–100).
Evidence summary:
The initial UK RFA registry of 335 patients with BE and neoplasia that received ER for visible lesion followed by RFA every 3 months until all areas of BE were ablated or cancer developed showed that by 12 months after initial RFA treatment CR-D was achieved in 81% and CR-IM in 62% of patients.24 The registry’s later report in 2015 (consisting of 508 patients) showed CR-D and CR-IM rates of 92% and 83%, respectively.3 There is increasing evidence to support the use of RFA25 post-ER of any visible lesion in order to achieve CR-IM in the first 12–18 months post initial endoscopic ablation. Data are lacking on how often and at which interval RFA should be provided to these patients; however, our panel of experts suggests that an interval of 2–4 months would be acceptable practice.
For patients undergoing RFA with a focal device, the dosimetry and treatment regimen is 12 J/cm2×3, without interval cleaning, and for patients undergoing RFA with a circumferential device the dosimetry and treatment regimen is 10 J/cm2–clean–10 J/cm2. 8 0.4 No disagreement 1 No disagreement N/A
Aspirational performance target: N/A.
Evidence summary:
Focal application of RFA without cleaning in between each ablation has been shown to be effective with 94% CR-D and 87% CR-IM, with a stenosis rate of 11%.26 A multicentre randomised trial by van Vilsteren et al 27 showed that a simplified ablative regimen (3×15 J/cm2–no clean) is highly effective and can achieve higher complete remission of residual BE islands (73% vs 67%) than the standard method (2×15 J/cm2–clean–2×15 J/cm2) at 2 months. The same group was also able to show that the simplified regimen without cleaning was able to achieve higher BE surface regression (88% vs 83%) in comparison with the standard regimen in circumferential balloon-based RFA with significantly shorter ablation time with the simplified technique (p<0.01).28 Furthermore, a multicentre RCT on focal RFA for dysplastic BE showed that the simplified RFA regimen (3×12 J/cm2, without cleaning) is non-inferior to the standard regimen (2×15 J/cm2, followed by cleaning, followed by 2×15 J/cm2), and therefore is the preferred RFA regimen for the management of patients with BE dysplasia.29
The volume of evidence supporting the use of the circumferential RFA device in published literature is increasing. Recent data have shown a regression of 78% of BE segment at 3 months postablation with the circumferential device using a dose of 12 J and 85% regression with 10 J.30 Furthermore a randomised trial in the Netherlands assessed treatment regimens for the 360 Express RFA balloon catheter (360 Express) using standard (1×10 J/cm2–clean–1×10 J/cm2), simple-double (2×10 J/cm2–no clean) and simple-single ablation regimen (1×10 J/cm2–no clean). The simple-double arm of the study was terminated early as a result of significant severe stenosis; however, the study was able to show higher median BE regression in the standard arm compared with the simple-single group: 85% (IQR 75–94), 95% CI 78% to 92% vs 73% (IQR 48–90), 95% CI 59% to 85% (p=0.009).30 It would therefore be appropriate to consider standard regimen (1×10 J/cm2–clean–1×10 J/cm2) for the use of the circumferential RFA device.
Centres undertaking BET should achieve CR-D ≥90% and CR-IM ≥80% within 18 months after the first treatment. 8 0.4 No disagreement 1 No disagreement N/A
Aspirational performance target: N/A.
Evidence summary:
The Ablation of Intestinal Metaplasia Containing Dysplasia trial included a 5-year follow-up analysis of patients with BE and dysplasia managed by RFA in a randomised controlled trial. Data showed BE recurrence after CR-IM by RFA in almost one-third of patients with baseline dysplastic BE. Most recurrences occurred during the first year after CR-IM. However, patients who achieved CR-IM and remained BE-free at 1 year after RFA had a low risk of BE recurrence.31 In addition, data from the UK RFA registry, the multicentre community practice registry and the multicentre interventional EURO II study have all shown that ET is capable of achieving CR-D in 81%–92% and CR-IM in 72%–87% of patients with BE neoplasia at 12 months.3 Recent systematic reviews and a meta-analysis have also shown that EMR followed by RFA in patients with early BE neoplasia can achieve CR-D of 91%–93% and CR-IM of 73%–78% with 5%–10% stricture rate, 1% bleeding rate and 0.2% perforation rate.22 Based on recent studies, the expert panel suggests that centres undertaking BET should aim for CR-D >90% and CR-IM >80% at 18 months after the first treatment, and end of treatment should be confirmed by two successive negative endoscopies, after which patients should receive follow-up endoscopies at appropriate intervals stratified according to risk of recurrence. The expert panel agreed that an 18-month time point is appropriate as standard clinical practice cannot always ensure timely visits and a 12-month time point would be too restrictive.
Patients with residual dysplasia after 18 months are to be rediscussed at an oesophagogastric MDT. 9 0.7 No disagreement 1 No disagreement 90 (80–100)
Aspirational performance target: 90% (range: 80–100).
Evidence summary:
The recurrence of neoplasia after ER can be significantly reduced if the residual BE is completely ablated. A prospective study by Pech et al showed a significant (96.6%) response to ET in patients with BE neoplasia. However, metachronous lesions in the BE segment developed in 21.5% of patients within 2 years. The risk factors most frequently associated with recurrence were piecemeal resection, long-segment BE, no ablative therapy of BE after complete response, time until complete response achieved >10 months and multifocal neoplasia.32 It is therefore recommended that all patients with residual BE neoplasia after 18 months of endotherapy are discussed in a dedicated OG neoplasia MDT and considered for further investigation and treatment.
Post-BET symptomatic stricture rate should not exceed 10%–15%. 8 0.5 No disagreement 1 No disagreement N/A
Aspirational performance target: N/A.
Evidence summary:
The documented SSR from several major studies range from 2.1% to 14%,33 requiring a median of 2–4 dilatations post-therapy. These also include data from EURO II study (SSR=6%),21 UK RFA registry (SSR=6.2%),3 and the meta-analyses by Yang et al (SSR=11.6%)33 and Qumseya et al (SSR=5.6%).34 EMR and ESD are increasingly used in the management of BE neoplasia, and stricture rates are expected to rise accordingly. It is therefore reasonable to suggest that all centres undertaking BET should not have SSR exceeding 10%–15% post-BET.

BE, Barrett’s oesophagus; BET, Barrett’s endotherapy; CR-D, complete remission of dysplasia; CR-IM, complete remission of intestinal metaplasia; EET, endoscopic eradication therapy; EMR, endoscopic mucosal resection; ER, endoscopic resection; ESD, endoscopic submucosal dissection; ET, endoscopic therapy; GI, gastrointestinal; HGD, high grade dysplasia; IPRAS, interpercentile range adjusted for symmetry; LGD, low grade dysplasia; MAD-M, mean absolute deviation from the median; MDT, multidisciplinary team; N/A, not applicable; OAC, oesophageal adenocarcinoma; OG, Oesophago-gastric; QI, quality indicator; RCT, randomised controlled trial; RFA, radiofrequency ablation; SSR, symptomatic stricture rate.