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@article{1808038,
author = {Werner, Y. B. and Hakanson, B. and Martinek, J. and Repici, A. and von, Rahden BHA. and Bredenoord, A. J. and Bisschops, R. and Messmann, H. and Vollberg, M. C. and Noder, T. and Kersten, J. F. and Mann, O. and Izbicki, J. and Pazdro, A. and Fumagalli, U. and Rosati, R. and Germer, C. T. and Schijven, M. P. and Emmermann, A. and von, Renteln D. and Fockens, P. and Boeckxstaens, G. and Rosch, T.},
article_location = {Waltham},
article_number = {23},
doi = {http://dx.doi.org/10.1056/NEJMoa1905380},
keywords = {PNEUMATIC DILATIONADVERSE EVENTSHELLER MYOTOMYPOEMOUTCOMESRISK},
language = {eng},
issn = {0028-4793},
journal = {New England Journal of Medicine},
note = {RIV/00023001:_____/19:00078661},
title = {Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia},
url = {https://www.nejm.org/doi/10.1056/NEJMoa1905380},
volume = {381},
year = {2019}
}
TY - JOUR
ID - 1808038
AU - Werner, Y. B. - Hakanson, B. - Martinek, J. - Repici, A. - von, Rahden BHA. - Bredenoord, A. J. - Bisschops, R. - Messmann, H. - Vollberg, M. C. - Noder, T. - Kersten, J. F. - Mann, O. - Izbicki, J. - Pazdro, A. - Fumagalli, U. - Rosati, R. - Germer, C. T. - Schijven, M. P. - Emmermann, A. - von, Renteln D. - Fockens, P. - Boeckxstaens, G. - Rosch, T.
PY - 2019
TI - Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia
JF - New England Journal of Medicine
VL - 381
IS - 23
SP - 2219-2229
EP - 2219-2229
PB - Massachussetts Medical Society
SN - 00284793
N1 - RIV/00023001:_____/19:00078661
KW - PNEUMATIC DILATIONADVERSE EVENTSHELLER MYOTOMYPOEMOUTCOMESRISK
UR - https://www.nejm.org/doi/10.1056/NEJMoa1905380
N2 - BACKGROUND Pneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODS In a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux. RESULTS A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%. CONCLUSIONS In this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM.
ER -
WERNER, Y. B., B. HAKANSON, J. MARTINEK, A. REPICI, Rahden BHA. VON, A. J. BREDENOORD, R. BISSCHOPS, H. MESSMANN, M. C. VOLLBERG, T. NODER, J. F. KERSTEN, O. MANN, J. IZBICKI, A. PAZDRO, U. FUMAGALLI, R. ROSATI, C. T. GERMER, M. P. SCHIJVEN, A. EMMERMANN, Renteln D. VON, P. FOCKENS, G. BOECKXSTAENS a T. ROSCH. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. \textit{New England Journal of Medicine}. Waltham: Massachussetts Medical Society, 2019, roč.~381, č.~23, s.~2219-2229. ISSN~0028-4793. Dostupné z: https://dx.doi.org/10.1056/NEJMoa1905380.
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