Condition category
Digestive System
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
22/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G E E Boeckxstaens

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7375
g.e.boeckxstaens@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR37

Study information

Scientific title

Acronym

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

Ethics approval received from the local ethics committee.

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Symptom control
2. Therapeutic success

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

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

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21561346
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23277105

Publication citations

  1. Results

    Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR, , Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia., N. Engl. J. Med., 2011, 364, 19, 1807-1816, doi: 10.1056/NEJMoa1010502.

  2. Results

    Rohof WO, Salvador R, Annese V, Bruley des Varannes S, Chaussade S, Costantini M, Elizalde JI, Gaudric M, Smout AJ, Tack J, Busch OR, Zaninotto G, Boeckxstaens GE, Outcomes of treatment for achalasia depend on manometric subtype., Gastroenterology, 2013, 144, 4, 718-25; quiz e13-4, doi: 10.1053/j.gastro.2012.12.027.

Additional files

Editorial Notes