European achalasia trial: a prospective randomised multi-centre study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia

ISRCTN	ISRCTN56304564
DOI	https://doi.org/10.1186/ISRCTN56304564
Secondary identifying numbers	NTR37

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr G E E Boeckxstaens
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 7375
Email	g.e.boeckxstaens@amc.uva.nl

Study design	Randomised, active controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	European achalasia trial: a prospective randomised multi-centre study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia
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.
Ethics approval(s)	Ethics approval received from the local ethics committee.
Condition	Achalasia
Intervention	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.
Intervention type	Other
Primary outcome measure	1. Symptom control 2. Therapeutic success
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/01/2003
Overall study end date	01/01/2013

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	200
Participant 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
Participant 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
Recruitment start date	01/01/2003
Recruitment end date	01/01/2013

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Academic Medical Centre (AMC) (The Netherlands)
University/education

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	12/05/2011	Yes	No
Results article	results	01/04/2013	Yes	No
Results article	results	01/05/2016	Yes	No

30/11/2015: Publication reference added.