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

NCT00671684 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-05-05

No results posted yet for this study

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.

Conditions

  • Chronic Constipation
  • Hirschsprung's Disease

Interventions

PROCEDURE

Endoscopic Mucosal Resection (EMR)

EMR is a common procedure in gastroenterology. The technique involves placing a band around a piece of mucosa in the GI tract. The band and the tissue are then removed using a cautery snare. The technique can be used to obtain tissue for diagnostic purposes or to remove lesions for therapeutic purposes.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Field F Willingham, MD, MPH · MGH

  • Garrett C Zella, MD · MGH

  • Mari Mino-Kenudson, MD · MGH

  • Braden Kuo, MD · MGH

  • William R Brugge, MD, FASGE · MGH

  • Leonel Rodriguez, MD · MGH

  • Clarissa Foy, NP · MGH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671684 on ClinicalTrials.gov