Peroral endoscopic myotomy (POEM) vs endoscopic balloon dilation (EBD) for the treatment of achalasia in childre

Recruiting

Conditions: Achalasia
Esophageal motility disorder
10017977

Registration Number: NL-OMON55648

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Newly diagnosed achalasia patients aged 7 - 18 years old with
- Eckardt score > 3;
- presence of a high resolution manometry pattern consistent with achalasia
type 1 or 2 according to the Chicago classification (CC) V3.0 criteria
- barium esophagram suggestive of achalasia

Exclusion Criteria

- Previous endoscopic or surgical treatment for achalasia
- Previous surgery of the upper gastrointestinal tract
- Known coagulopathy
- Liver cirrhosis and/or esophageal varices
- Known grade >=B esophagitis
- Barrett*s esophagus
- Known pregnancy at time of treatment
- Stricture of the esophagus
- Presence of malignant or premalignant esophageal lesions
- Hiatal hernia > 1cm
- Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the
esophagus
- Barium esophagram suggestive for other pathologies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is treatment success, defined as a Eckardt score of 3 or less<br /><br>in the absence of the need for endoscopic or surgical retreatment and the<br /><br>absence of severe complications associated with treatment. The primary endpoint<br /><br>is measured after 1 year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life and achalasia-specific quality of life<br /><br>- Stasis in the oesophagus, measured with a timed barium oesophagogram<br /><br>- Presence of reflux symptoms, reflux oesophagitis and excessive oesophageal<br /><br>acid exposure<br /><br>- Lower oesophageal sphincter pressure and integrative relaxation pressure<br /><br>(IRP4), as measured with high-resolution impedance manometry<br /><br>- Complications of the treatment, defined as any unwanted events that arise<br /><br>following treatment and/or that are secondary to the treatment. Complications<br /><br>are classified as severe when these result in admission > 24 hours or<br /><br>prolongation of an already planned admission of >24 hours, admission to a<br /><br>medium or intensive care unit, additional endoscopic procedures, or blood<br /><br>transfusion or death. Other complications are classified as mild.</p><br>