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 |
| Protocol serial number | NTR37 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 30/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G E E Boeckxstaens
Scientific
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | European achalasia trial: a prospective randomised multi-centre study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
1. Symptom control |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 |
Editorial Notes
30/11/2015: Publication reference added.
