View Clinical Trial (Medical Research Study)
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Constipation - Hirschsprung Disease |
| Purpose: |
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Background: Adult and pediatric patients presenting with chronic constipation and/or
motility disorders may be referred for rectal biopsy to rule out aganglionosis or
Hirschsprung's disease. The traditional diagnostic test, rectal suction biopsy, is a blind
technique and is insensitive in confirming the diagnosis. Frequently, patients require
subsequent referral for a surgical full thickness biopsy.
Hypothesis: Endoscopic mucosal resection (EMR) will improve the diagnostic yield for
aganglionosis and decrease the need for subsequent surgical full thickness biopsy.
Methods: This is a prospective, single center, controlled investigation of EMR for the
diagnosis of colonic aganglionosis / Hirschsprung's disease. Patients who are offered
rectal suction biopsy will be offered enrollment. Enrolled patients will have one
additional procedure (EMR) at the time of their rectal suction biopsy. Specimens will be
analyzed pathologically for size, submucosal tissue adequacy, the presence of ganglionic
tissue, and positivity by acetylcholinesterase staining. The adequacy of the tissue
specimen, the proportion of diagnostic specimens, and the proportion of patients that would
have required subsequent referral for full thickness biopsy, will be compared. Variable
such as cost and recovery time will be compared. Biopsy results will be compared with
patient's pre-endoscopy clinical data including their history of constipation, results of
SITZ marker studies, Bristol stool scale, and anorectal manometry.
Results: The primary outcome variable will be the proportion of patients with a diagnostic
specimen in each group. Secondary outcome variables will include the size of the specimen,
the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of
the acetylcholinesterase stain. The biopsy results will also be correlated with patient's
clinical data including clinical history, Bristol stool scale, anorectal manometry results,
and SITZ marker studies. Cost and recovery time will be compared.
Discussion: The proposed investigation may demonstrate that a simple endoscopic test, which
uses direct visualization, can improve the diagnostic yield of rectal biopsies for
Hirschsprung's disease, and spare patients an additional surgical full thickness rectal
biopsy.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 10 years of age or older
- offered Rectal Suction biopsy
Exclusion Criteria:
- any contraindication to general anesthesia or conscious sedation
- contraindication to endoscopy
- untreated or unmanageable coagulopathy
- thrombocytopenia (<50)
- inability to provide informed consent.
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| NCT ID: |
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NCT01515501 |
| Primary Contact: |
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Principal Investigator
Braden Kuo, M.D.
Massachusetts General Hospital
Nicole K Comosa, B.S.
Phone: 6177260196
Email: ncomosa@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
Nicole K Comosa, B.S.
Phone: 617-726-0196
Email: ncomosa@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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