Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease (EDGE)

Mass General Brigham

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hirschsprung's Disease; Chronic Constipation

Treatments: Procedure: Endoscopic Mucosal Resection (EMR)

Study type: Interventional

Funder types: Other

Identifiers

NCT00671684

2007P001577

Details and patient eligibility

About

The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.

Enrollment: 50 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients offered a rectal suction biopsy

Exclusion criteria

• any contraindication to general anesthesia or conscious sedation
• contraindication to endoscopy
• untreated or unmanageable coaguloapathy
• thrombocytopenia (<50)
• inability to provide informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)