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Achalasia-Specific Quality of Life After Pneumatic Dilation or Laparoscopic Heller Myotomy With Partial Fundoplication: A Multicenter, Randomized Clinical Trial

Chrystoja, Caitlin C HBsc1,2; Darling, Gail E MD3; Diamant, Nicholas E MD4; Kortan, Paul P MD5; Tomlinson, George A PhD6,7; Deitel, Wayne MD8; Laporte, Audrey PhD1; Takata, Julie MA2; Urbach, David R MD1,2,9 for the Canadian Achalasia Trial Study Group

American Journal of Gastroenterology: November 2016 - Volume 111 - Issue 11 - p 1536–1545
doi: 10.1038/ajg.2016.402
ORIGINAL CONTRIBUTIONS: ESOPHAGUS
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Objectives: 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.

1Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

2Division of Support, Systems and Outcomes, University Healthy Network, Toronto, Ontario, Canada

3Division of Thoracic Surgery, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada

4Division of Gastroenterology, Department of Medicine, University Health Network, Toronto, Ontario, Canada

5Division of Gastroenterology, Department of Medicine, St Michael's Hospital, Toronto, Ontario, Canada

6Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

7Department of Medicine, University Health Network and Mount Sinai Hospital, Toronto, Ontario, Canada

8Department of Medical Imaging, St Michael’s Hospital and University of Toronto, Toronto, Ontario, Canada

9Department of Surgery, Women’s College Hospital and University of Toronto, Toronto, Ontario, Canada

Correspondence: David R. Urbach, MD,, Women's College Hospital, 76 Grenville Street, Room 8332, Toronto, Ontario M5S 1B2, Canada. E-mail: david.urbach@wchospital.ca

SUPPLEMENTARY MATERIAL accompanies this paper at http://links.lww.com/AJG/A946

Received 02 November 2015; accepted 26 July 2016

Guarantors of the article: Caitlin C. Chrystoja, HBsc, and David R. Urbach, MD.

Specific author contributions: C.C.C. and D.R.U. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: G.E.D., N.E.D., P.P.K., G.A.T., W.D., A.L., J.T., and D.R.U. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: all authors. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: C.C.C., G.A.T., J.T., and D.R.U. Obtained funding: D.R.U. Administrative, technical, or material support: J.T., W.D., and G.A.T. Study supervision: G.E.D., N.E.D., P.P.K., and D.R.U.

Financial support: This study was funded by the Canadian Institutes of Health Research (MCT-76449). The funder of the study had no role in study design, data collection, data analysis, data interpretation, writing of the report, or decision to submit the manuscript for publication.

Potential competing interests: None.

© The American College of Gastroenterology 2016. All Rights Reserved.
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