[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493255":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":12,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":12,"maxAge":12,"enrollmentInfo":62,"targetDuration":12,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fundacion Miguel Servet","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-endoscopic treatment group (Group NE)","NO_INTERVENTION","Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018, CAL will be classified into three groups according to severity (I,II,III) and empirical antibiotic treatment will be started according to the recommendations of said guideline",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Endoscopic treatment group (EUS-GBD Group)","EXPERIMENTAL","The procedure will be performed after at least 6 hours of fasting The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy.",[18],"Procedure: Endoscopic treatment group (EUS-GBD group",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"PROCEDURE","Endoscopic treatment group (EUS-GBD group","The placement of a endoscopic drain performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Jesús JU Urmán, PhD","CONTACT","+(34) 8484422222","jmurmanf@gmail.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital Universitario de Navarra","RECRUITING","Pamplona","Navarre","31008","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-1.64323,42.81687,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":29,"phoneExt":12,"email":30},"Jesús Urman, PhD",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Jesus Maria Urman Fernandez","Head of Pancreas Unit","100493255","endosonography-guided-gallbladder-drainage-vs-non-endoscopic-treatment-in-inoperable-acute-cholecystitis-100493255",false,"NCT05702775","Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis","Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)","EUS-DRAIN","Inclusion Criteria:\n\n* Patient older than 18 years.\n* Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.\n* Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index \\> 5 and\u002For Karnofsky \\\u003C 50 or decision of the patient not to have surgery.\n* Signature of the informed consent of the study\n\nExclusion Criteria:\n\n* Operable acute cholecystitis.\n* Refusal of the patient to participate in the study.\n* Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.\n* Ascites.\n* Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.\n* Patients with decompensated cirrhosis, portal hypertension and\u002For gastric varices\n* Coagulopathy with uncorrectable INR\\>1.5 or thrombocytopenia \\\u003C50,000\u002Fmm3 uncorrectable.\n* Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia).\n* Hemodynamic instability.\n* Baseline ECOG \\>=4\n* Survival expectancy \\\u003C 6 months","ALL",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"NA","In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs.\n\nThe ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC.\n\nOurworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.",[70],"Cholecystitis, Acute",[72,73,74],"Cholecystitis","Non-operable","Endoscopic","2023-01-18",{"date":77,"type":78},"2023-01-27","ACTUAL",{"date":80,"type":78},"2022-10-01",{"date":82,"type":64},"2026-07-01",{"name":5,"class":6},1]