Achalasia-Specific Quality of Life After Pneumatic Dilation or Laparoscopic Heller Myotomy With Partial Fundoplication: A Multicenter, Randomized Clinical Trial.
OBJECTIVE
Achalasia is a chronic, progressive, and incurable esophageal motility disease. There is clinical uncertainty about which treatment should be recommended as first-line therapy. Our objective was to evaluate the effectiveness of pneumatic dilation compared with laparoscopic Heller myotomy with partial fundoplication in improving achalasia-specific quality of life.


METHODS
This was a prospective, multicenter, randomized trial at five academic hospitals in Canada. Fifty previously untreated adults with a clinical diagnosis of primary achalasia, confirmed by manometric testing, were enrolled between November 2005 and March 2010, and followed for 5 years after treatment. Randomization was stratified by site, in random blocks of size four and with balanced allocation. Patients were treated with pneumatic dilation or laparoscopic Heller myotomy with partial fundoplication. The primary outcome was the difference between the treatments in the mean improvement of the achalasia severity questionnaire (ASQ) score at 1 year from baseline. Prespecified secondary outcomes included general and gastrointestinal quality of life, symptoms, esophageal physiology measures (lower esophageal sphincter relaxation and pressure, esophageal emptying, abnormal esophageal acid exposure), complications, and incidence of retreatment. Functional and imaging studies were performed blinded and all outcome assessors were blinded.


RESULTS
There were no significant differences between treatments in the improvement of ASQ score at 1 year from baseline (27.5 points in the Heller myotomy arm vs. 20.2 points in the pneumatic dilation arm; difference 7.3 points, 95% confidence interval -4.7 to 19.3; P=0.23). There were no differences between treatments in improvement of symptoms, general and gastrointestinal quality of life, or measures of esophageal physiology. Improvements in ASQ score diminished over time for both interventions. At 5 years, there were no differences between treatments in improvement of ASQ score, symptoms, and general or gastrointestinal quality of life. There were no serious adverse events. No patient who received Heller myotomy required retreatment, whereas five patients treated initially with pneumatic dilation required retreatment.


CONCLUSIONS
Treatment with pneumatic dilation or laparoscopic Heller myotomy similarly improves achalasia-specific disease severity at 1 year. Either of the therapeutic approaches can be used as first-line therapy for previously untreated adults with achalasia.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.|Division of Support, Systems and Outcomes, University Healthy Network, Toronto, Ontario, Canada.
Caitlin C
CC
Chrystoja
Division of Thoracic Surgery, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
Gail E
GE
Darling
Division of Gastroenterology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.
Nicholas E
NE
Diamant
Division of Gastroenterology, Department of Medicine, St Michael's Hospital, Toronto, Ontario, Canada.
Paul P
PP
Kortan
Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.|Department of Medicine, University Health Network and Mount Sinai Hospital, Toronto, Ontario, Canada.
George A
GA
Tomlinson
Department of Medical Imaging, St Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.
Wayne
W
Deitel
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Audrey
A
Laporte
Division of Support, Systems and Outcomes, University Healthy Network, Toronto, Ontario, Canada.
Julie
J
Takata
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.|Division of Support, Systems and Outcomes, University Healthy Network, Toronto, Ontario, Canada.|Department of Surgery, Women's College Hospital and University of Toronto, Toronto, Ontario, Canada.
David R
DR
Urbach
D000328:Adult; D000368:Aged; D002170:Canada; D013505:Digestive System Surgical Procedures; D004106:Dilatation / Q000379:methods*; D004931:Esophageal Achalasia / Q000175:diagnosis / Q000601:surgery*; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D005260:Female; D018662:Fundoplication / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome