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European achalasia trial: a prospective randomised multi-centre study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia
ISRCTN ISRCTN56304564
DOI 10.1186/ISRCTN56304564
ClinicalTrials.gov identifier
EudraCT number
Public title European achalasia trial: a prospective randomised multi-centre study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia
Scientific title
Acronym N/A
Serial number at source NTR37
Study hypothesis The major aim of this prospective, randomised, multi-centre study is to compare the two treatments, namely pneumatic dilation and laparoscopic Heller myotomy.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local ethics committee.
Study design Randomised, active controlled, parallel group, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Achalasia
Participants - inclusion criteria 1. Between 18 and 75 years of age
2. Manometric diagnosis of achalasia
3. Eckardt score greater than three
4. Signed informed consent
Participants - exclusion criteria 1. Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
2. Previous treatment except treatment with nitroderivatives
3. Ca++ channel blockers or sildenafil or dilation with Savary bougies or balloons of 2 cm diameter or smaller
4. Pseudo-achalasia
5. Mega-oesophagus (greater than 7 cm)
6. Previous oesophageal or gastric surgery (except for gastric perforation)
7. Not capable of filling out questionnaires (i.e. due to language barrier)
8. Not available for follow-up
9. Oesophageal diverticula in the distal oesophagus
Anticipated start date 01/01/2003
Anticipated end date 01/01/2013
Status of trial Completed
Patient information material
Target number of participants 200
Interventions Pneumatic dilation versus laparoscopic Heller myotomy.

Subjects will be followed during 10 years. 1 month after treatment a manometry and an oesophageal 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.
Primary outcome measure(s) 1. Symptom control
2. Therapeutic success
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Academic Medical Centre (AMC) (The Netherlands)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21561346
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23277105
Contact name Dr  G E E  Boeckxstaens
  Address Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 566 7375
  Fax +31 (0)20 691 7033
  Email g.e.boeckxstaens@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (The Netherlands)
  Address Emma Kinderziekenhuis
Postbus 22660
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 04/08/2005
Last edited 22/05/2013
Date ISRCTN assigned 04/08/2005
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