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

NCT ID: NCT00671684

Last Updated: 2008-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Constipation Hirschsprung's Disease

Keywords

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Hirschsprung's disease Constipation Endoscopy, digestive system Diagnosis Colonoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hosptial

Principal Investigators

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Field F Willingham, MD, MPH

Role: STUDY_DIRECTOR

MGH

Garrett C Zella, MD

Role: STUDY_DIRECTOR

MGH

Mari Mino-Kenudson, MD

Role: STUDY_DIRECTOR

MGH

Braden Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

William R Brugge, MD, FASGE

Role: STUDY_DIRECTOR

MGH

Leonel Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Clarissa Foy, NP

Role: STUDY_DIRECTOR

MGH

Locations

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Massachusetts General Hosptial

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2007P001577

Identifier Type: -

Identifier Source: org_study_id