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

Primary Purpose

Chronic Constipation, Hirschsprung's Disease

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Mucosal Resection (EMR)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Constipation focused on measuring Hirschsprung's disease, Constipation, Endoscopy, digestive system, Diagnosis, Colonoscopy

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hosptial

Outcomes

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.

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.

Full Information

First Posted
May 1, 2008
Last Updated
May 2, 2008
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00671684
Brief Title
Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease
Acronym
EDGE
Official Title
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation, Hirschsprung's Disease
Keywords
Hirschsprung's disease, Constipation, Endoscopy, digestive system, Diagnosis, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Endoscopic Mucosal Resection (EMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Field F Willingham, MD, MPH
Organizational Affiliation
MGH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Garrett C Zella, MD
Organizational Affiliation
MGH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mari Mino-Kenudson, MD
Organizational Affiliation
MGH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Braden Kuo, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William R Brugge, MD, FASGE
Organizational Affiliation
MGH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leonel Rodriguez, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clarissa Foy, NP
Organizational Affiliation
MGH
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hosptial
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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