Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial.

After the first interim analysis (performed, in accordance with the protocol after 40% (n=34) patients completed 6 months follow-up), the DSMB recommended to stop further enrolment as the analysis showed a highly significant result (p=0.003) in favour of the active treatment arm.

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However, similarly to other two studies, we showed a trend that post-G-POEM distensibility ˃ 13 mm Hg/mm 2 might predict treatment success. 17 37 We experienced 10 SAEs, but only 3 were related to pyloromyotomy.

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