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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671684

Acronym

EDGE

Enrollment

Registered

2008-05-05

Start date

2007-10-31

Completion date

2009-04-30

Last updated

2008-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation, Hirschsprung's Disease

Keywords

Hirschsprung's disease, Constipation, Endoscopy, digestive system, Diagnosis, Colonoscopy

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.

Interventions

PROCEDUREEndoscopic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026