[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610049":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ONE STENT ARM","ACTIVE_COMPARATOR","Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease",[13],"Procedure: ERCP with one stent placement",{"label":15,"type":10,"description":16,"interventionNames":17},"TWO STENT ARM","Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease.",[18],"Procedure: ERCP with two stent placement",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","ERCP with one stent placement","One transpapillary cystic duct stent will be placed into the gallbladder via ERCP",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"ERCP with two stent placement","Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP",[15],[31],{"name":32,"affiliation":5,"role":33},"Eric Vargas","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Liz Lemke","CONTACT","507-266-3317","Lemke.Elizabeth@mayo.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-92.4699,44.02163,{"lat":52,"lon":51},[55,56],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Eric J. Vargas Valls","Principal Investigator","100610049","one-vs-two-stents-for-gallbladder-disease-100610049",false,"NCT07222527","One vs. Two Stents for Gallbladder Disease","A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates","Inclusion Criteria:\n\n1. Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.\n2. Age 18-95.\n3. Participants must be willing and able to provide informed consent\n4. Referred for ERCP for management of 1) suspected choledocholithiasis 2) acute biliary pancreatitis and\u002For 3) acute cholangitis in whom cholecystectomy is expected to be delayed \\> 30 days or are deemed to not be surgical candidates for cholecystectomy.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I\u002FII) precluding standard ERCP\n3. History of primary sclerosing cholangitis\n4. History of gallbladder cancer\n5. History of cholecystectomy\n6. Unsuccessful biliary cannulation during ERCP -","ALL","18 Years","95 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) among patients who are not immediate surgical candidates for removal of their gallbladder.\n\nThe study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and technical success, defined as successful placement of stents into the gallbladder.\n\nThe main questions it aims to answer are:\n\n1. Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?\n2. Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies?\n\nResearchers will compare outcomes between patients randomized to one stent versus two stents to determine which approach provides better long-term gallbladder drainage and fewer recurrent events.\n\nParticipants will:\n\nBe evaluated for eligibility and provide informed consent prior to undergoing an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopy where a guidewire is placed into the bile duct from the small intestine.\n\nThey will then undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents.\n\nAll participants will receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention.",[78,79,80,81],"Recurrent Cholecystitis","Cholecystitis","Symptomatic Gallbladder Disease","Biliary Colic",[83,84,85,86,87,88,89,90,91,92],"gallbladder disease","symptomatic gallbladder disease","Recurrent cholecystitis","biliary colic","cystic duct stent","transpapillary gallbladder stents","high surgical risk patient","nonsurgical management gallbladder disease","gallbladder decompression","acute cholecystitis in non-cholecystectomy candidate","2025-12-12",{"date":95,"type":96},"2025-12-16","ACTUAL",{"date":93,"type":96},{"date":99,"type":72},"2028-05-27",{"name":5,"class":6},1]