European Achalasia Trial.
- Registration Number
- NL-OMON26612
- Brief Summary
Pneumatic Dilation versus Laparoscopic Heller’s Myotomy for Idiopathic Achalasia<br> Guy E. Boeckxstaens, M.D., Ph.D., Vito Annese, M.D., Ph.D., Stanislas Bruley des Varannes, M.D., Ph.D., Stanislas Chaussade, M.D., Ph.D., Mario Costantini, M.D., Ph.D., Antonello Cuttitta, M.D., J. Ignasi Elizalde, M.D., Uberto Fumagalli, M.D., Ph.D., Marianne Gaudric, M.D., Ph.D., Wout O. Rohof, M.D., André J. Smout, M.D., Ph.D., Jan Tack, M.D., Ph.D., Aeilko H. Zwinderman, Ph.D., Giovanni Zaninotto, M.D., Ph.D., and Olivier R. Busch, M.D., Ph.D., for the European Achalasia Trial Investigators<br> n engl j med 364;19 nejm.org may 12, 2011
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Between 18-75 yr of age, manometric diagnosis of achalasia, Eckardt score >3, signed informed consent.
Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk, previous treatment except treatment with nitroderivatives, Ca++ channel blockers or sildenafil or dilation with Savary bougies or balloons of 2 cm diameter or smaller, pseudo-achalasia, mega-esophagus (> 7cm), previous esophageal or gastric surgery (except for gastric perforation), not capable to fill out questionnaires (f.e. due to language barrier), not available for follow-up, esophageal diverticula in the distal esophagus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Symptom control;<br /><br>2. Therapeutic succes.
- Secondary Outcome Measures
Name Time Method