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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Massachusetts General Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671684
First Posted: May 5, 2008
Last Update Posted: May 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
May 1, 2008
May 5, 2008
May 5, 2008
October 2007
April 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Chronic Constipation
  • Hirschsprung's Disease
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
April 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00671684
2007P001577
No
Not Provided
Not Provided
Leonel Rodriguez, MD, Massachusetts General Hosptial
Massachusetts General Hospital
Not Provided
Study Director: Field F Willingham, MD, MPH MGH
Study Director: Garrett C Zella, MD MGH
Study Director: Mari Mino-Kenudson, MD MGH
Principal Investigator: Braden Kuo, MD MGH
Study Director: William R Brugge, MD, FASGE MGH
Principal Investigator: Leonel Rodriguez, MD MGH
Study Director: Clarissa Foy, NP MGH
Massachusetts General Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP