Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Chronic Constipation, Hirschsprung's Disease
In brief
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.
Key facts
- Study ID
- NCT00671684
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2007-10-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2008-05-05
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients offered a rectal suction biopsy
You may not qualify if…
- any contraindication to general anesthesia or conscious sedation
- contraindication to endoscopy
- untreated or unmanageable coaguloapathy
- thrombocytopenia (<50)
- inability to provide informed consent.
Where it is running
- Massachusetts General Hosptial — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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