An Moonen1, Vito Annese2, Ann Belmans3, Albert J Bredenoord4, Stanislas Bruley des Varannes5, Mario Costantini6, Bertrand Dousset7, J I Elizalde8, Uberto Fumagalli9, Marianne Gaudric10, Antonio Merla11, Andre J Smout4, Jan Tack1, Giovanni Zaninotto12, Olivier R Busch13, Guy E Boeckxstaens1. 1. Department of Gastroenterology, Catholic University of Leuven, Leuven, Belgium. 2. Head of Gastroenterology, Department of Emergency, AOU Careggi, Florence, Italy. 3. Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU, Leuven, Belgium. 4. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. 5. Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France. 6. Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy. 7. Department of GI and Endocrine Surgery, Hôpital Cochin, Paris, France. 8. Department of Gastroenterology, Hospital Clínic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain. 9. Upper GI Surgery, Humanitas Clinical and Research Hospital, Rozzano, Italy. 10. Department of Gastroenterology, Hopital Cochin, Paris, France. 11. Division of Gastroenterology, IRCCS, "Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 12. Department of Academic Surgery, St Mary's Hospital, Imperial College, London, UK. 13. Gastrointestinal Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Abstract
OBJECTIVE: Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. DESIGN:201 newly diagnosed patients with achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. RESULTS: In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs. 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. CONCLUSIONS: After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for achalasia. TRIAL REGISTRATION NUMBERS: Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
OBJECTIVE:Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. DESIGN: 201 newly diagnosed patients with achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. RESULTS: In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs. 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PDpatients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. CONCLUSIONS: After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PDpatients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for achalasia. TRIAL REGISTRATION NUMBERS: Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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