{ "FullStudy":{ "Rank":217890, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515501", "OrgStudyIdInfo":{ "OrgStudyId":"MGH2007p001577" }, "Organization":{ "OrgFullName":"Massachusetts General Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)", "OfficialTitle":"Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)", "Acronym":"EDGE" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2007", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 14, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 16, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Branden Kuo", "ResponsiblePartyInvestigatorTitle":"Instructor in Medicine, Harvard Medical School", "ResponsiblePartyInvestigatorAffiliation":"Massachusetts General Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Massachusetts General Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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.", "DetailedDescription":"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.\n\nHypothesis: Endoscopic mucosal resection (EMR) will improve the diagnostic yield for aganglionosis and decrease the need for subsequent surgical full thickness biopsy.\n\nMethods: 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.\n\nResults: 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.\n\nDiscussion: 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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Constipation", "Hirschsprung Disease" ] }, "KeywordList":{ "Keyword":[ "Constipation", "Hirschsprung Disease" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"12", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Endoscopic mucosal resection", "ArmGroupType":"Other", "ArmGroupDescription":"At time of rectal section biopsy all subjects will under go the additional intervention of an endoscopic muscosal resection.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Endoscopic mucosal resection (EMR)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Endoscopic mucosal resection (EMR)", "InterventionDescription":"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.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Endoscopic mucosal resection" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The number of EMR Biopsies that are diagnostic specimens", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"One Year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n10 years of age or older\noffered Rectal Suction biopsy\n\nExclusion Criteria:\n\nany contraindication to general anesthesia or conscious sedation\ncontraindication to endoscopy\nuntreated or unmanageable coagulopathy\nthrombocytopenia (<50)\ninability to provide informed consent.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"10 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Braden Kuo, M.D.", "OverallOfficialAffiliation":"Massachusetts General Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Massachusetts General Hospital", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02114", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"17255831", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"15202044", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"7693906", "ReferenceType":"background", "ReferenceCitation":"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." },{ "ReferencePMID":"16769331", "ReferenceType":"background", "ReferenceCitation":"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." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006627", "ConditionMeshTerm":"Hirschsprung Disease" },{ "ConditionMeshId":"D000003248", "ConditionMeshTerm":"Constipation" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012817", "ConditionAncestorTerm":"Signs and Symptoms, Digestive" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000004065", "ConditionAncestorTerm":"Digestive System Abnormalities" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000008531", "ConditionAncestorTerm":"Megacolon" },{ "ConditionAncestorId":"D000003108", "ConditionAncestorTerm":"Colonic Diseases" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000000013", "ConditionAncestorTerm":"Congenital Abnormalities" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5055", "ConditionBrowseLeafName":"Constipation", "ConditionBrowseLeafAsFound":"Constipation", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8286", "ConditionBrowseLeafName":"Hirschsprung Disease", "ConditionBrowseLeafAsFound":"Hirschsprung Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14205", "ConditionBrowseLeafName":"Signs and Symptoms, Digestive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12", "ConditionBrowseLeafName":"Congenital Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5837", "ConditionBrowseLeafName":"Digestive System Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10097", "ConditionBrowseLeafName":"Megacolon", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4919", "ConditionBrowseLeafName":"Colonic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2818", "ConditionBrowseLeafName":"Hirschsprung's Disease", "ConditionBrowseLeafAsFound":"Hirschsprung Disease", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }