ISRCTN74448884
Active, not recruiting
未知
Peroral endoscopic myotomy vs endoscopic balloon dilation for the treatment of achalasia in children
Amsterdam University Medical Centers0 sites80 target enrollmentFebruary 18, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Achalasia
- Sponsor
- Amsterdam University Medical Centers
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Eckardt score \>3
- •2\. Presence of a HRM pattern consistent with achalasia type I or II according to the Chicago classification (CC) V3\.0 criteria
- •3\. Age 7 years up to 17 years inclusive
Exclusion Criteria
- •1\. Achalasia type III (this extremely rare subtype in children that is accompanied by esophageal spasm and associated complaints has a worse prognosis compared to type I and II. Literature and expert\-opinion based recommendations suggest to treat type III with POEM. Randomizing these patients to EBD with a high a priori risk of relapses is therefore considered unethical)
- •2\. Previous surgical or endoscopical achalasia treatment
- •3\. Previous surgery of the upper gastrointestinal tract
- •4\. Known coagulopathy
- •5\. Known Liver cirrhosis and/or esophageal varices
- •6\. Known LA grade \=B esophagitis
- •7\. Known Barrett’s esophagus
- •8\. Known pregnancy at time of treatment
- •9\. Stricture of the esophagus
- •10\. Known presence of malignant or premalignant esophageal lesions
Outcomes
Primary Outcomes
Not specified
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