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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial

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 Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: 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. [ Time Frame: April 2009 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: April 2009 ]

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: May 1, 2008
Date Started: October 2007
Date Completion: April 2009
Last Updated: May 2, 2008
Last Verified: May 2008