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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00671684
Other study ID # 2007P001577
Secondary ID
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


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
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