NCT00671684

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 5, 2008

Status Verified

May 1, 2008

Enrollment Period

1.5 years

First QC Date

May 1, 2008

Last Update Submit

May 2, 2008

Conditions

Chronic ConstipationHirschsprung's Disease

Keywords

Hirschsprung's diseaseConstipationEndoscopy, digestive systemDiagnosisColonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Endoscopic Mucosal Resection (EMR)PROCEDURE

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 Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients offered a rectal suction biopsy

You may not qualify if:

  • any contraindication to general anesthesia or conscious sedation
  • contraindication to endoscopy
  • untreated or unmanageable coaguloapathy
  • thrombocytopenia (\<50)
  • inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hirschsprung DiseaseConstipationDisease

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Field F Willingham, MD, MPH

    MGH

    STUDY DIRECTOR

  • Garrett C Zella, MD

    MGH

    STUDY DIRECTOR

  • Mari Mino-Kenudson, MD

    MGH

    STUDY DIRECTOR

  • Braden Kuo, MD

    MGH

    PRINCIPAL INVESTIGATOR

  • William R Brugge, MD, FASGE

    MGH

    STUDY DIRECTOR

  • Leonel Rodriguez, MD

    MGH

    PRINCIPAL INVESTIGATOR

  • Clarissa Foy, NP

    MGH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 5, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 5, 2008

Record last verified: 2008-05

Locations

US(1)