{ "FullStudy":{ "Rank":218000, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514058", "OrgStudyIdInfo":{ "OrgStudyId":"IRB00018166" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"CCCWFU 01711", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Wake Forest University Health Sciences" } ] }, "Organization":{ "OrgFullName":"Wake Forest University Health Sciences", "OrgClass":"OTHER" }, "BriefTitle":"A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction", "OfficialTitle":"A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Terminated", "WhyStopped":"new clinical strategies have rendered the question posed by this study less relevant", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 8, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 10, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Wake Forest University Health Sciences", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No", "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Patients who present with obstructive jaundice due to a malignant stricture often undergo a battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not available at many centers, patients often undergo an initial ERCP procedure with stent placement (which is more widely available) prior to referral for EUS. It has been reported that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing, and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the EUS with FNA procedure may also be compromised in patients with biliary stents. As such, diagnosis and treatment options may be delayed. One retrospective study of 65 subjects showed a significant difference in the number of correctly staged pancreatic head cancers (mainly T stage) in patients without stents versus those with biliary stents (85% vs 47%).2 A second retrospective study concluded that tissue diagnosis is not influenced in patients with stents placed greater than 24 hours before the EUS; however, patients with stents placed just prior to the EUS (less than 24 hours) were more likely to have indeterminate results.1 Although the findings are suggestive, the studies are limited by their retrospective design and these questions have not yet been addressed in a prospective study.\n\nBoth procedures require anesthesia, and when performed sequentially in the same setting, the duration of anesthesia is prolonged. This is concerning for the patient since complications may theoretically increase with prolonged anesthesia. However, a retrospective review at a tertiary referral center showed that combined EUS and ERCP yielded a complication rate no higher than that of the component procedures.3\n\nAt our institution, the current practice is to sequentially perform both EUS and ERCP in the same setting for patients with suspected malignant biliary obstruction. Typically, EUS-FNA is performed first, followed by ERCP.\n\nHypothesis We hypothesize that performing ERCP with biliary stenting immediately prior to EUS-FNA will decrease the diagnostic yield of EUS-FNA and diminish the ability of EUS to accurately stage pancreas tumors. Conversely, performing EUS-FNA prior to ERCP will increase biliary cannulation time and increase success rate.\n\nThe objectives of this study are as follows:\n\nDetermine the diagnostic yield of EUS-FNA (for diagnosis of cancer vs benign process) when performed either immediately before or after ERCP with biliary stenting (primary outcome)\nDetermine the ability of EUS to accurately stage pancreatic masses (T and N staging) when performed either immediately before or after ERCP with biliary stenting (secondary outcome) in comparison to the gold standard of surgical pathology post resection or in comparison to CT findings (in those patients who are not surgical candidates)\nDetermine the biliary cannulation time (the time it takes to successfully pass a wire into the common bile duct from the start of the procedure) and success rate of placing a biliary stent during ERCP when performed either immediately before or after EUS-FNA (secondary outcome)" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Jaundice" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"8", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"EUS-FNA First", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients will undergo EUS-FNA first, followed by ERCP with biliary stenting (using a plastic stent).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: EUS-FNA first, followed by CRCP with bilinary stenting" ] } },{ "ArmGroupLabel":"ERCP with stent placement first", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients will undergo ERCP with stent placement first, followed by EUS-FNA.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: ERCP with stent placement, followed by EUS-FNA" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"EUS-FNA first, followed by CRCP with bilinary stenting", "InterventionDescription":"EUS-FNA first, followed by CRCP with bilinary stenting (using a plastic stent)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "EUS-FNA First" ] } },{ "InterventionType":"Procedure", "InterventionName":"ERCP with stent placement, followed by EUS-FNA", "InterventionDescription":"ERCP with stent placement, followed by EUS-FNA", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "ERCP with stent placement first" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Cytological yield (adequate versus inadequate for diagnosis) of EUS-FNA prior to stent placement vs post stent placement", "PrimaryOutcomeDescription":"Cytological yield will be defined by the ability of the pathologist to render a diagnosis based on the material supplied to them during the procedure (adequate vs inadequate tissue to make a diagnosis of malignant vs benign disease).", "PrimaryOutcomeTimeFrame":"1 day" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must be able to review and sign informed consent.\nSubjects must require biliary stenting for the relief of their symptoms as well as FNA biopsy for proper diagnosis.\nSuspected mass should be located in the head, uncinate, or neck of the pancreas.\n\nExclusion Criteria:\n\nCannot give and sign informed consent.\nThe suspected mass is located in the body or tail of the pancreas.\nThe patient may be a candidate for palliative biliary stenting (in which a metal stent would be placed)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"John A Evans, MD", "OverallOfficialAffiliation":"Wake Forest University Health Sciences", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Wake Forest Baptist Health", "LocationCity":"Winston-Salem", "LocationState":"North Carolina", "LocationZip":"27157", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007565", "ConditionMeshTerm":"Jaundice" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006932", "ConditionAncestorTerm":"Hyperbilirubinemia" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000012877", "ConditionAncestorTerm":"Skin Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9178", "ConditionBrowseLeafName":"Jaundice", "ConditionBrowseLeafAsFound":"Jaundice", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8566", "ConditionBrowseLeafName":"Hyperbilirubinemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14263", "ConditionBrowseLeafName":"Skin Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }