title: Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia.
abstract: BACKGROUND
  Many experts consider laparoscopic Heller's myotomy (LHM) to be superior to pneumatic dilation for the treatment of achalasia, and LHM is increasingly considered to be the treatment of choice for this disorder.
  
  
  METHODS
  We randomly assigned patients with newly diagnosed achalasia to pneumatic dilation or LHM with Dor's fundoplication. Symptoms, including weight loss, dysphagia, retrosternal pain, and regurgitation, were assessed with the use of the Eckardt score (which ranges from 0 to 12, with higher scores indicating more pronounced symptoms). The primary outcome was therapeutic success (a drop in the Eckardt score to ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for retreatment, pressure at the lower esophageal sphincter, esophageal emptying on a timed barium esophagogram, quality of life, and the rate of complications.
  
  
  RESULTS
  A total of 201 patients were randomly assigned to pneumatic dilation (95 patients) or LHM (106). The mean follow-up time was 43 months (95% confidence interval [CI], 40 to 47). In an intention-to-treat analysis, there was no significant difference between the two groups in the primary outcome; the rate of therapeutic success with pneumatic dilation was 90% after 1 year of follow-up and 86% after 2 years, as compared with a rate with LHM of 93% after 1 year and 90% after 2 years (P=0.46). After 2 years of follow-up, there was no significant between-group difference in the pressure at the lower esophageal sphincter (LHM, 10 mm Hg [95% CI, 8.7 to 12]; pneumatic dilation, 12 mm Hg [95% CI, 9.7 to 14]; P=0.27); esophageal emptying, as assessed by the height of barium-contrast column (LHM, 1.9 cm [95% CI, 0 to 6.8]; pneumatic dilation, 3.7 cm [95% CI, 0 to 8.8]; P=0.21); or quality of life. Similar results were obtained in the per-protocol analysis. Perforation of the esophagus occurred in 4% of the patients during pneumatic dilation, whereas mucosal tears occurred in 12% during LHM. Abnormal exposure to esophageal acid was observed in 15% and 23% of the patients in the pneumatic-dilation and LHM groups, respectively (P=0.28).
  
  
  CONCLUSIONS
  After 2 years of follow-up, LHM, as compared with pneumatic dilation, was not associated with superior rates of therapeutic success. (European Achalasia Trial Netherlands Trial Register number, NTR37, and Current Controlled Trials number, ISRCTN56304564.).
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands. guy.boeckxstaens@med.kuleuven.be
authors.forename: Guy E
authors.initials: GE
authors.lastname: Boeckxstaens
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Stanislas Bruley
authors.initials: SB
authors.lastname: des Varannes
authors.forename: Stanislas
authors.initials: S
authors.lastname: Chaussade
authors.forename: Mario
authors.initials: M
authors.lastname: Costantini
authors.forename: Antonello
authors.initials: A
authors.lastname: Cuttitta
authors.forename: J Ignasi
authors.initials: JI
authors.lastname: Elizalde
authors.forename: Uberto
authors.initials: U
authors.lastname: Fumagalli
authors.forename: Marianne
authors.initials: M
authors.lastname: Gaudric
authors.forename: Wout O
authors.initials: WO
authors.lastname: Rohof
authors.forename: André J
authors.initials: AJ
authors.lastname: Smout
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.forename: Aeilko H
authors.initials: AH
authors.lastname: Zwinderman
authors.forename: Giovanni
authors.initials: G
authors.lastname: Zaninotto
authors.forename: Olivier R
authors.initials: OR
authors.lastname: Busch
mesh_terms: D000328:Adult; D002404:Catheterization / Q000009:adverse effects; D016009:Chi-Square Distribution; D004931:Esophageal Achalasia / Q000601:surgery* / Q000628:therapy*; D004939:Esophageal Perforation / Q000209:etiology; D049630:Esophageal Sphincter, Lower / Q000601:surgery; D004947:Esophagus / Q000293:injuries; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D012307:Risk Factors; D016896:Treatment Outcome