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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Branden Kuo, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01515501
First received: January 11, 2012
Last updated: September 21, 2015
Last verified: September 2015
  Purpose
Patients undergoing routine rectal suction biopsy will undergo as part of the study an additional Endoscopic mucosal resection. The biopsy results will also be correlated with patient's clinical data including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.

Condition Intervention Phase
Constipation
Hirschsprung Disease
Procedure: Endoscopic mucosal resection (EMR)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The number of EMR Biopsies that are diagnostic specimens [ Time Frame: One Year ] [ Designated as safety issue: No ]
    The adequacy of the tissue specimen, the proportion of diagnostic specimens, and the proportion of patients that would have required subsequent referral for full thickness biopsy, will be compared. Variable such as cost and recovery time will be compared. Biopsy results will be compared with patient's pre-endoscopy clinical data including their history of constipation, results of SITZ marker studies, Bristol stool scale, and anorectal manometry.


Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endoscopic mucosal resection
At time of rectal section biopsy all subjects will under go the additional intervention of an endoscopic muscosal resection.
Procedure: Endoscopic mucosal resection (EMR)
EMR uses an endoscope to take a tissue sample from the rectum. It is the same type of instrument used in a routine colonoscopy. It is hoped that this procedure will help diagnose Hirschsprung's Disease more often than by recal suction biopsy alone, which can often be unclear and result in more invasive surgery for diagnosis.

Detailed Description:

Background: Adult and pediatric patients presenting with chronic constipation and/or motility disorders may be referred for rectal biopsy to rule out aganglionosis or Hirschsprung's disease. The traditional diagnostic test, rectal suction biopsy, is a blind technique and is insensitive in confirming the diagnosis. Frequently, patients require subsequent referral for a surgical full thickness biopsy.

Hypothesis: Endoscopic mucosal resection (EMR) will improve the diagnostic yield for aganglionosis and decrease the need for subsequent surgical full thickness biopsy.

Methods: This is a prospective, single center, controlled investigation of EMR for the diagnosis of colonic aganglionosis / Hirschsprung's disease. Patients who are offered rectal suction biopsy will be offered enrollment. Enrolled patients will have one additional procedure (EMR) at the time of their rectal suction biopsy. Specimens will be analyzed pathologically for size, submucosal tissue adequacy, the presence of ganglionic tissue, and positivity by acetylcholinesterase staining. The adequacy of the tissue specimen, the proportion of diagnostic specimens, and the proportion of patients that would have required subsequent referral for full thickness biopsy, will be compared. Variable such as cost and recovery time will be compared. Biopsy results will be compared with patient's pre-endoscopy clinical data including their history of constipation, results of SITZ marker studies, Bristol stool scale, and anorectal manometry.

Results: The primary outcome variable will be the proportion of patients with a diagnostic specimen in each group. Secondary outcome variables will include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain. The biopsy results will also be correlated with patient's clinical data including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.

Discussion: The proposed investigation may demonstrate that a simple endoscopic test, which uses direct visualization, can improve the diagnostic yield of rectal biopsies for Hirschsprung's disease, and spare patients an additional surgical full thickness rectal biopsy.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 years of age or older
  • offered Rectal Suction biopsy

Exclusion Criteria:

  • any contraindication to general anesthesia or conscious sedation
  • contraindication to endoscopy
  • untreated or unmanageable coagulopathy
  • thrombocytopenia (<50)
  • inability to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515501

Contacts
Contact: Braden Kuo, M.D. 6177260196 ldimisko@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nicole K Comosa, B.S.    617-726-0196    ncomosa@partners.org   
Principal Investigator: Braden Kuo, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Braden Kuo, M.D. Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Branden Kuo, Instructor in Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01515501     History of Changes
Other Study ID Numbers: MGH2007p001577 
Study First Received: January 11, 2012
Last Updated: September 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Constipation
Hirschsprung Disease

Additional relevant MeSH terms:
Constipation
Hirschsprung Disease
Colonic Diseases
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Megacolon
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on February 04, 2016