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European Achalasia Trial.


- candidate number0
- NTR NumberNTR37
- ISRCTNISRCTN56304564
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR2-jun-2005
- Secondary IDsN/A 
- Public TitleEuropean Achalasia Trial.
- Scientific TitleA prospective randomized multi-center study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAchalasia
- Inclusion criteriaBetween 18-75 yr of age, manometric diagnosis of achalasia, Eckardt score >3, signed informed consent.
- Exclusion criteriaSevere 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-jan-2014
- Target number of participants200
- InterventionsThe major aim of this prospective, randomized, multi-center study is to compare the two treatments, namely pneumatic dilation and laparoscopic Heller myotomy.
- Primary outcome1. Symptom control;
2. Therapeutic succes.
- Secondary outcomeN/A
- TimepointsEvery year.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. G.E.E. Boeckxstaens
- CONTACT for SCIENTIFIC QUERIESDr. G.E.E. Boeckxstaens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gastroenterology
- PublicationsPneumatic Dilation versus Laparoscopic Hellerís Myotomy for Idiopathic Achalasia
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
n engl j med 364;19 nejm.org may 12, 2011
- Brief summaryMulti-center study; Subjects will be followed during several years, as long as possible. 1 month after treatment a manometry and an esophageal emptying will be performed and will be repeated every year. 1 year after treatment an endoscopy (+ Lugol staining) and 24h pH metry will be performed and will be repeated every 3 years.
- Main changes (audit trail)
- RECORD11-jul-2005 - 6-dec-2012


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