The Hybrid-APC study: initial results of a Multicenter Observational Study on Barrett Esophagus treatment

Aims Preliminary data from a prospective, single-arm, multicenter observational study to evaluate the initial treatment success of the Hybrid-APC (H-APC) technique, which combines argon plasma coagulation (APC) with a previous saline injection for ablation therapy of neoplastic Barrett's esophagus (BE). This technique is being evaluated as an alternative to radiofrequency (RFA), the current gold standard.

Methods We prospectively collected data from 57 patients with BE (mean length C of 0.58 SD 0.94 and mean length M of 2.44 S.D. 1.31) who underwent H-APC ablation in 4 Italian Hospitals. None of them had undergone previous ablative therapy for BE. 18 patients are still ongoing, and one patient was lost after one treatment session.

Treatment duration depended on the required number of endoscopic sessions at two months (±2 weeks) intervals until complete eradication of visible intestinal metaplasia. Maximum 50% of the circumference could be treated per treatment session. Complete Eradication of dysplasia (CE-D) and Complete Eradication of Intestinal Metaplasia (CE-IM) were confirmed by biopsy samples taken on neo epithelium after complete eradication of visible BE. After 7 days (+/- 2 days) from each session patients received a phone call from the local advisor to assess pain and dysphagia.

Results Of the 57 enrolled patient, 43.9% were previously treated with endoscopic resection for visible lesion (one case – 1.75% – of LGD, 21,1% HGD with one case with also a G1 NET; 21,1% PT1a), while 56.1% started directly with ablation as no visible lesions were found. Among the 38 patients who completed the treatment so far CE-D and CE-IM were 100% after a mean of 1.5 ablation sessions. 65.8% of them achieved the primary outcome with just one treatment session with a mean duration of 22.8 minutes SD 11.96.

Until November 2023, 89 ablations sessions were performed and no major complications have been reported except for one case of electrocoagulation syndrome post-ablation, conservatively managed. Tolerability showed very promising results with mean reported pain score after the first ablation session of 1.77/10 and mean dysphagia score of 1.4/10.

Conclusions Hybrid-APC appears to have high efficacy and safety, with a high tolerability profile and a limited number of treatment sessions required to achieve initial CE-D and CE-IM. Prospective randomized comparative studies are still needed to have final evidence of its effectiveness.

Conflicts of interest

Authors do not have any conflict of interest to disclose.

Publikationsverlauf

Artikel online veröffentlicht:
15. April 2024