Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia
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Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. / Werner, Yuki B; Hakanson, Bengt; Martinek, Jan; Repici, Alessandro; von Rahden, Burkhard H A; Bredenoord, Albert J; Bisschops, Raf; Messmann, Helmut; Vollberg, Marius C; Noder, Tania; Kersten, Jan F; Mann, Oliver; Izbicki, Jakob; Pazdro, Alexander; Fumagalli, Uberto; Rosati, Riccardo; Germer, Christoph-Thomas; Schijven, Marlies P; Emmermann, Alice; von Renteln, Daniel; Fockens, Paul; Boeckxstaens, Guy; Rösch, Thomas.
In: NEW ENGL J MED, Vol. 381, No. 23, 05.12.2019, p. 2219-2229.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia
AU - Werner, Yuki B
AU - Hakanson, Bengt
AU - Martinek, Jan
AU - Repici, Alessandro
AU - von Rahden, Burkhard H A
AU - Bredenoord, Albert J
AU - Bisschops, Raf
AU - Messmann, Helmut
AU - Vollberg, Marius C
AU - Noder, Tania
AU - Kersten, Jan F
AU - Mann, Oliver
AU - Izbicki, Jakob
AU - Pazdro, Alexander
AU - Fumagalli, Uberto
AU - Rosati, Riccardo
AU - Germer, Christoph-Thomas
AU - Schijven, Marlies P
AU - Emmermann, Alice
AU - von Renteln, Daniel
AU - Fockens, Paul
AU - Boeckxstaens, Guy
AU - Rösch, Thomas
N1 - Copyright © 2019 Massachusetts Medical Society.
PY - 2019/12/5
Y1 - 2019/12/5
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. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).
AB - 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. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).
U2 - 10.1056/NEJMoa1905380
DO - 10.1056/NEJMoa1905380
M3 - SCORING: Journal article
C2 - 31800987
VL - 381
SP - 2219
EP - 2229
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 23
ER -