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

Phase 1

• Conditions: Chronic Constipation; Hirschsprung's Disease

• Registration Number: NCT00671684
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2008-05
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Last Update Submitted: 2008-05-02
• Study First Posted: 2008-05-05
• Last Update Posted: 2008-05-05
• Primary Completion: 2009-04
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy.	April 2009

Secondary Outcome Measures

Name	Time	Method
Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain.	April 2009

Trial Locations

Locations (1)

Massachusetts General Hosptial; 🇺🇸 Boston, Massachusetts, United States