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

Chronic Constipation Clinical Trial

— EDGE  

Official title:

Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00671684
• Other study ID #: 2007P001577
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: May 1, 2008
• Last updated: May 2, 2008
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: May 2008
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Hirschsprung Disease
• Hirschsprung's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hosptial	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		April 2009	No
Secondary	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.		April 2009	No