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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00671684
First received: May 1, 2008
Last updated: May 2, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Chronic Constipation
Hirschsprung's Disease
Procedure: Endoscopic Mucosal Resection (EMR)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671684

Locations
United States, Massachusetts
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Leonel Rodriguez, MD, Massachusetts General Hosptial
ClinicalTrials.gov Identifier: NCT00671684     History of Changes
Other Study ID Numbers: 2007P001577
Study First Received: May 1, 2008
Last Updated: May 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Hirschsprung's disease
Constipation
Endoscopy, digestive system
Diagnosis
Colonoscopy

Additional relevant MeSH terms:
Hirschsprung Disease
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014