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ENDOSCOPIC ERADICATION THERAPY WITH MULTIFOCAL CRYOBALLOON ABLATION FOR BARRETT'S ESOPHAGUS RELATED NEOPLASIA: PRELIMINARY RESULTS FROM A PROSPECTIVE EUROPEAN MULTICENTER STUDY
Date
May 7, 2023
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Society: ASGE
Background
Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett’s esophagus (BE) related neoplasia. This prospective, European multicenter study (Euro-Coldplay, NTR NL7253) aimed to evaluate the efficacy and safety of FCBA for the treatment of limited BE.
Method
In eight European Barrett referral centers, patients with C≤2M≤5 BE with an indication for ablation therapy were eligible for inclusion. Before entry, any visible lesion had to be removed by endoscopic resection (max. 2cm in length and 50% of circumference). FCBA was performed by experienced and trained endoscopists at 3 month intervals until complete endoscopic eradication of BE (max. 5 sessions). During every session, the esophagogastric junction was treated circumferentially followed by all visible BE using side-by-side ablations with a dose of 8 seconds per ablation. After at least two FCBA sessions, add-on treatment was allowed with either argon plasma coagulation (APC) for BE lesions of <5mm (max. 2 sessions) or a single endoscopic mucosal resection for lesions of >5mm. Outcomes included complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D), and adverse event rate.
Results
107 patients (91 males; mean age 65) with a median BE length of C0M2 were included, containing low-grade dysplasia (32%), high-grade dysplasia (32%) or early cancer (39%) as worst baseline histology. Currently, 84/107 (79%) patients have finished the treatment phase of which the results are reported hereafter. 57/84 (68%) patients underwent endoscopic resection at entry followed by a median of 2 (IQR 2-2) FCBA treatments with a median of 7 (IQR 6-9) ablations per treatment session. Only one patient (1/84; 1%) could not be treated with FCBA owing to a device malfunction requiring a switch to radiofrequency ablation. During the treatment phase, 3/84 (4%) patients developed a new visible, neoplastic lesion amenable for endoscopic resection (high-grade dysplasia n=2, low-risk T1 cancer n=1). Add-on treatment after at least two FCBA sessions was performed in 32/84 (38%) patients, of whom the most were treated with APC (31/32; 97%). CE-D was achieved in 95% (80/84) and CE-IM in 93% (78/84), per intention-to-treat analysis. Per-protocol analysis, CE-D and CE-IM were achieved in 100% (80/80) and 98% (78/80), respectively. Esophageal stricture was the most common adverse event in 13/84 (15%) patients, which resolved after a median of 2 (IQR 1-4) dilations. No perforation or bleeding were observed, while buried BE glands were seen in 1/84 (1%).
Conclusion
In expert hands, endoscopic eradication therapy with FCBA seems to be highly effective with an acceptable safety profile for patients with limited BE. Long-term follow-up is warranted to evaluate the durability of the treatment response.
Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett’s esophagus (BE) related neoplasia. This prospective, European multicenter study (Euro-Coldplay, NTR NL7253) aimed to evaluate the efficacy and safety of FCBA for the treatment of limited BE.
Method
In eight European Barrett referral centers, patients with C≤2M≤5 BE with an indication for ablation therapy were eligible for inclusion. Before entry, any visible lesion had to be removed by endoscopic resection (max. 2cm in length and 50% of circumference). FCBA was performed by experienced and trained endoscopists at 3 month intervals until complete endoscopic eradication of BE (max. 5 sessions). During every session, the esophagogastric junction was treated circumferentially followed by all visible BE using side-by-side ablations with a dose of 8 seconds per ablation. After at least two FCBA sessions, add-on treatment was allowed with either argon plasma coagulation (APC) for BE lesions of <5mm (max. 2 sessions) or a single endoscopic mucosal resection for lesions of >5mm. Outcomes included complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D), and adverse event rate.
Results
107 patients (91 males; mean age 65) with a median BE length of C0M2 were included, containing low-grade dysplasia (32%), high-grade dysplasia (32%) or early cancer (39%) as worst baseline histology. Currently, 84/107 (79%) patients have finished the treatment phase of which the results are reported hereafter. 57/84 (68%) patients underwent endoscopic resection at entry followed by a median of 2 (IQR 2-2) FCBA treatments with a median of 7 (IQR 6-9) ablations per treatment session. Only one patient (1/84; 1%) could not be treated with FCBA owing to a device malfunction requiring a switch to radiofrequency ablation. During the treatment phase, 3/84 (4%) patients developed a new visible, neoplastic lesion amenable for endoscopic resection (high-grade dysplasia n=2, low-risk T1 cancer n=1). Add-on treatment after at least two FCBA sessions was performed in 32/84 (38%) patients, of whom the most were treated with APC (31/32; 97%). CE-D was achieved in 95% (80/84) and CE-IM in 93% (78/84), per intention-to-treat analysis. Per-protocol analysis, CE-D and CE-IM were achieved in 100% (80/80) and 98% (78/80), respectively. Esophageal stricture was the most common adverse event in 13/84 (15%) patients, which resolved after a median of 2 (IQR 1-4) dilations. No perforation or bleeding were observed, while buried BE glands were seen in 1/84 (1%).
Conclusion
In expert hands, endoscopic eradication therapy with FCBA seems to be highly effective with an acceptable safety profile for patients with limited BE. Long-term follow-up is warranted to evaluate the durability of the treatment response.
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