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Clinical Trials/ISRCTN74448884
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.

Registry
who.int
Start Date
February 18, 2022
End Date
December 31, 2026
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Amsterdam University Medical Centers

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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