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

NCT01515501 | Completed DMC

• 1 other identifier: MGH2007p001577
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation; Hirschsprung Disease

Keywords

Constipation; Hirschsprung Disease

Outcome Measures

Primary Outcomes (1)

• The number of EMR Biopsies that are diagnostic specimens

  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.

  One Year

Study Arms (1)

Endoscopic mucosal resection

OTHER

At time of rectal section biopsy all subjects will under go the additional intervention of an endoscopic muscosal resection.

Procedure: Endoscopic mucosal resection (EMR)

Interventions

Endoscopic mucosal resection (EMR) PROCEDURE

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.

Endoscopic mucosal resection

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• offered Rectal Suction biopsy

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Croffie JM, Davis MM, Faught PR, Corkins MR, Gupta SK, Pfefferkorn MD, Molleston JP, Fitzgerald JF. At what age is a suction rectal biopsy less likely to provide adequate tissue for identification of ganglion cells? J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):198-202. doi: 10.1097/01.mpg.0000252188.12793.ee.

  PMID: 17255831 BACKGROUND

• Hurlstone DP, Cross SS, Drew K, Adam I, Shorthouse AJ, Brown S, Sanders DS, Lobo AJ. An evaluation of colorectal endoscopic mucosal resection using high-magnification chromoscopic colonoscopy: a prospective study of 1000 colonoscopies. Endoscopy. 2004 Jun;36(6):491-8. doi: 10.1055/s-2004-814397.

  PMID: 15202044 BACKGROUND

• Hirose R, Hirata Y, Yamada T, Kawana T, Taguchi T, Suita S. The simple technique of rectal mucosal biopsy for the diagnosis of Hirschsprung's disease. J Pediatr Surg. 1993 Jul;28(7):942-4. doi: 10.1016/0022-3468(93)90703-n.

  PMID: 7693906 BACKGROUND

• Pini-Prato A, Martucciello G, Jasonni V. Rectal suction biopsy in the diagnosis of intestinal dysganglionoses: 5-year experience with Solo-RBT in 389 patients. J Pediatr Surg. 2006 Jun;41(6):1043-8. doi: 10.1016/j.jpedsurg.2006.01.070.

  PMID: 16769331 BACKGROUND

MeSH Terms

Conditions

Constipation; Hirschsprung Disease

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Braden Kuo, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine, Harvard Medical School

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 24, 2012
• Study Start: October 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)