search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Reflux symptoms in patients with achalasia.


- candidate number14322
- NTR NumberNTR3838
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2013
- Secondary IDsNL42367.018.12 METC AMC
- Public TitleReflux symptoms in patients with achalasia.
- Scientific TitleReflux symptoms in patients with achalasia.
- ACRONYMN/A
- hypothesisThe aim of the study is to investigate the underlying mechanisms of gastroesophageal reflux and gastroesophageal reflux symptoms in treated achalasia patients. It is hypothesized that gastroesophageal reflux symptoms in treated patients with achalasia are dependent on retention and fermentation of food due to a reduced clearance by aperistalsis of the esophageal body rather than the result of true acid reflux episodes.
- Healt Condition(s) or Problem(s) studiedAchalasia, Gastroesophageal reflux Disease (GERD)
- Inclusion criteriaGroup I - Treated achalasia patients with gastroesophageal reflux symptoms:
1. Diagnosis of idiopathic achalasia confirmed by esophageal manometry that shows the following criteria:
A. Aperistalsis or simultaneous contractions in the esophageal body;
B. LES dysrelaxation.
2. Treatment of achalasia with one of the following procedures:
A. Endoscopic balloon dilatation;
B. Surgical Heller myotomy;
C. Per-Oral Endoscopic Myotomy (POEM).
3. Minimum total score on the GastroEsophageal Reflux Disease Questionnaire (GERDQ) of 8 or higher;
4. Gastroesophageal symptoms after treatment lasting more than 3 months;
5. Age 18-80 years;
6. Written informed consent.

Group II - Treated achalasia patients without gastroesophageal reflux symptoms:
1. Diagnosis of idiopathic achalasia confirmed by esophageal manometry that shows the following criteria:
A. Aperistalsis or simultaneous contractions in the oesophageal body;
B. LES dysrelaxation.
2. Treatment of achalasia with one of the following procedures:
A. Endoscopic balloon dilatation;
B. Surgical Heller myotomy;
C. Per-Oral Endoscopic Myotomy (POEM).
3. Maximum total score on the GastroEsophageal Reflux Disease Questionnaire (GERDQ) of below 8;
4. No gastroesophageal symptoms after treatment;
5. Age 18-80 years;
6. Written informed consent.
- Exclusion criteriaGroup I - Treated achalasia patients with gastroesophageal reflux symptoms:
1. Pseudoachalasia;
2. Upper gastrointestinal malignancy;
3. Chagas disease;
4. Peptic ulcer disease;
5. Inability to stop PPI, H2-receptor antagonist or prokinetic drug for two weeks;
6. Presence of an extremely dilated oesophagus body >5 cm.

Group II - Treated achalasia patients without gastroesophageal reflux symptoms:
1. Pseudoachalasia;
2. Upper gastrointestinal malignancy;
3. Chagas disease;
4. Peptic ulcer disease;
5. Inability to stop PPI, H2-receptor antagonist or prokinetic drug for two weeks;
6. Presence of an extremely dilated oesophagus body >5 cm.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-feb-2013
- planned closingdate15-feb-2015
- Target number of participants40
- InterventionsStudy subjects will have to fill in four questionnaires (SF-36, Achalasia-DSQoL, GerdQ and Eckardt score) and will undergo five different measurements in two following days.

The following measurements will be performed:
1. Impedance planimetry using Endo Functional Luminal Imaging Probe (EndoFLIP);
2. Bernstein test (acid perfusion test);
3. High Resolution Manometry (HRM);
4. 24-hour pH-impedance monitoring;
5. Timed barium esophagography.
- Primary outcomeGastroesophageal reflux episodes.
- Secondary outcome1. LES pressure;
2. Esophagogastric junction distensibility;
3. Sensitivity to acid perfusion and distensibility;
4. Level of esophageal stasis;
5. Width/diameter of the esophagus.
- TimepointsAt baseline study subjects will have to fill in four questionnaires:
1. SF-36;
2. Achalasia-DSQoL;
3. GerdQ;
4. Eckardt score.

During two subsequent days, starting at baseline, five different measurements will be performed. Some measurements will be performed partly simultaneous. The measurements will be performed in the following order:
First day:
1. Impedance planimetry using Endo Functional Luminal Imaging Probe (EndoFLIP);
2. Bernstein test (acid perfusion test);
3. High Resolution Manometry (HRM);
4. 24-hour pH-impedance monitoring partly simultaneous with the HRM measurement.
Second day:
4. 24-hour pH-impedance monitoring;
5. Timed barium esophagography.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A.J. Bredenoord
- CONTACT for SCIENTIFIC QUERIESDr. A.J. Bredenoord
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryAchalasia is a rare motility disorder of the esophagus that is characterised by aperistalsis of the esophageal body and dysrelaxation of the lower esophageal sphincter (LES). Current treatment is palliative and the aim of the treatment is to diminish the obstructive function of the esophagogastric junction (EGJ). Due to this approach the most frequent complication post-treatment is gastroesophageal reflux (GER). However, not every treated patient develops GER symptoms and the mechanism behind the occurrence of GER in treated achalasia is unclear. Understanding this mechanism is important for further treatment of these symptoms and could have consequences for the choice of the initial treatment for achalasia. Therefore, the aim of this study is to investigate the underlying mechanisms of GER and GER symptoms in treated achalasia patients.
Adult treated achalasia patients with and without GER symptoms are included. The required sample size is calculated at 40 study subjects, 20 treated achalasia patients with GER symptoms will be compared to 20 treated achalasia patients without GER symptoms. The primary outcome is gastroesophageal reflux episodes. Secondary outcomes are LES pressure, esophagogastric junction distensibility, sensitivity to acid perfusion and distensibility, level of esophageal stasis and the width/diameter of the esophagus. In two subsequent days five measurements will be performed an EndoFLIP, an acid perfusion test, esophageal high resolution manometry, pH-impedance monitoring and at the end a barium esophagogram. Furthermore at baseline, symptom and quality of life questionnaires will be administered. The measurements are standard procedures that are routinely performed at the motility center of the Gastroenterology department in the evaluation of achalasia patients. Further follow-up after the two study days is not required.

Recruiting country: the Netherlands.
- Main changes (audit trail)
- RECORD4-feb-2013 - 13-feb-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl