Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
Long-Term Outcomes of Peroral Endoscopic Myotomy vs Pneumatic Dilation After Prior Laparoscopic Heller Myotomy for Achalasia.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Wessels Elise M, Masclee Gwen M C, Bastiaansen Barbara A J, Saleh Caroline M C, Tack Jan, Boeckxstaens Guy, Costamagna Guido, Familiari Pietro, Fockens Paul, Schijven Marlies P, Bisschops Raf, Bredenoord Albert J
Аннотация
BACKGROUND & AIMS: Peroral endoscopic myotomy (POEM) demonstrated higher efficacy at 1-year follow-up compared with pneumatic dilation (PD) in patients after failed laparoscopic Heller myotomy (LHM). The aim of this study was to evaluate the 5-year efficacy and safety of POEM compared with PD in patients with achalasia after failed LHM.
METHODS: This study reports the long-term follow-up results of a previously published multicenter randomized controlled trial performed in the Netherlands, Belgium, and Italy. Adult patients with achalasia confirmed by esophageal manometry were included when they had recurrent symptoms after LHM. Patients were randomized to PD 30 to 35 mm or POEM in a 1:1 ratio. The primary outcome was treatment success at 5-year follow-up, defined as Eckardt score ≤3 without retreatment. Patients who underwent additional dilation once up to 40 mm within 1 year after initial PD were not considered as treatment failure. Intention-to-treat analysis was applied for the primary outcome.
RESULTS: In total, 90 patients were included between January 2014 and June 2020 and randomized to PD (n = 45) or POEM (n = 45). At 5-year follow-up, treatment success was 11% after PD (n = 5/45) and 40% after POEM (n = 18/45) with a relative risk of 3.60 (95% confidence interval, 1.46-8.66; P = .002). Median time to treatment failure was 12 months for PD and 60 months for POEM (P = .005). Reflux esophagitis grade B to D was observed in 11% of the patients after POEM (n = 4/37) and in 9% after PD (n = 3/34) (P = .548). No procedure-related serious adverse events were reported between 1-year and 5-year follow-up.
CONCLUSIONS: POEM is more effective than PD at 5-year follow-up in patients with achalasia after failed LHM.
CLINICAL TRIAL REGISTRY: Dutch Trial Registry (NL4361; NTR4501).
METHODS: This study reports the long-term follow-up results of a previously published multicenter randomized controlled trial performed in the Netherlands, Belgium, and Italy. Adult patients with achalasia confirmed by esophageal manometry were included when they had recurrent symptoms after LHM. Patients were randomized to PD 30 to 35 mm or POEM in a 1:1 ratio. The primary outcome was treatment success at 5-year follow-up, defined as Eckardt score ≤3 without retreatment. Patients who underwent additional dilation once up to 40 mm within 1 year after initial PD were not considered as treatment failure. Intention-to-treat analysis was applied for the primary outcome.
RESULTS: In total, 90 patients were included between January 2014 and June 2020 and randomized to PD (n = 45) or POEM (n = 45). At 5-year follow-up, treatment success was 11% after PD (n = 5/45) and 40% after POEM (n = 18/45) with a relative risk of 3.60 (95% confidence interval, 1.46-8.66; P = .002). Median time to treatment failure was 12 months for PD and 60 months for POEM (P = .005). Reflux esophagitis grade B to D was observed in 11% of the patients after POEM (n = 4/37) and in 9% after PD (n = 3/34) (P = .548). No procedure-related serious adverse events were reported between 1-year and 5-year follow-up.
CONCLUSIONS: POEM is more effective than PD at 5-year follow-up in patients with achalasia after failed LHM.
CLINICAL TRIAL REGISTRY: Dutch Trial Registry (NL4361; NTR4501).