Peroral endoscopic myotomy (Z-POEM) vs. flexible endoscopic septotomy for treatment of Zenker diverticulum: preliminary results of international, multicenter, randomized, single-blind, clinical trial

Aims Flexible endoscopic septotomy (FES) is considered standard treatment of Zenker diverticulum (ZD) because of its safety and excellent efficacy. However, it usually requires multiple sessions and recurrencies seem frequent because of incomplete cutting of the septum. Moreover, it involves an incision of the full thickness of diverticular septum hence, the risk of adverse events might be higher. Peroral endoscopic myotomy for ZD (Z-POEM) is a new emerging technique, with theoretical potential to overcome the limitations mentioned above. Our aim was to compare the efficacy and safety of the Z-POEM and FES.

Methods We performed a prospective, randomized multicenter, single-blind, clinical trial in 7 centers accross Europe and the United States. Patients with symptomatic ZD measuring between 10 and 50mm in length were included. All investigators had extensive experience with both third space endoscopy (including Z-POEM) and FES. Efforts were made to standardize both procedures accross study centers, with on-line discussion and by providing videos of standardized procedures. Symptoms were assessed at baseline and 1, 6, 12 and 24 months after treatment using multiple scores, with the Kothari-Haber Symptom Score as a primary one. Main outcome was clinical success at 24 months. Clinical success was defined as Kothari-Haber Symptom Score<3 points without a need for additional treatment. Here we report preliminary data on secondary outcome measures: technical success rates, clinical success rates at 1 and 6 months of the follow-up, and adverse events rate. Adverse events were assessed 1 month after the procedure according to the appropriate classification (AEs during third space endoscopy)

Results A total of 156 patients (mean age 70 years, 44.2% female, mean Charlson comorbidity index 2.9) were randomly assigned to Z-POEM (79 patients) or FES (77 patients). At baseline mean size of the ZD was 26.7 mm, median symptom duration was 22 months and mean Kothari-Haber Symptom Score was 6.5. Mean Milano-Zenker score was 4.7, with no significant differences between the treatment groups. All procedures were technically successful. Mean procedure time was 24.9 min in the Z-POEM group and 17.1 min in the FES group (p=0.001). Clinical success at 1 and 6 months was 92.4% and 84.8% in the Z-POEM group and 92.2% and 81.8% in the FES group, respectively (p=0.96 and 0.62). Adverse events were observed in 2 patients (2.5%) in the Z-POEM group and in 6 patients (8.2%) in the FES group (p=0.12). All four (5.48%) severe adverse events were observed in the FES group (p=0.036).

Conclusions Short-term clinical success rates are comparable between Z-POEM and FES. Procedure time is shorter for the FES but at the higher risk of severe adverse events.

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Artikel online veröffentlicht:
27. März 2025