[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590452":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":70,"collaborators":18,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":18,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":61,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Hospital General Universitario de Alicante","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cholecystoscopy, gallbladder cleaning and removal of lumen-apposing metal stent","ACTIVE_COMPARATOR","Elective upper gastrointestinal endoscopy to perform cholecystoscopy, cleaning and removal of gallbladder (GB) stones and retrieval of the Lumen Apposing Metal Stent (LAMS) will be conducted 1 month after endoscopic ultrasound-guided GB drainage. For persistent GB stones, consecutive procedures will be performed weekly until complete cleaning and retrieval of the LAMS. A coaxial double pigtail plastic stent (7 or 10 Fr x 3 cm) will be placed indefinitely to maintain the fistula between the GB and the digestive tract.",[13],"Procedure: Cholecystoscopy and gallbladder cleaning",{"label":15,"type":16,"description":17,"interventionNames":18},"Conservative treatment: Indwelling stent","NO_INTERVENTION","Patients in the conservative group will not be scheduled for endoscopic revision during the one-year follow-up. The LAMS will only be reviewed as part of routine practice for suspected LAMS related complications",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Cholecystoscopy and gallbladder cleaning","Upper gastrointestinal endoscopy and cholecystoscopy are performed 4 weeks after GB drainage. A standard gastroscope is used to inspect the gallbladder cavity with retrieval or lithotripsy of residual stones until complete cleaning of the GB is achieved. Several procedures may be required to achieve complete stone clearance.\n\nFinally, the LAMS is retrieved and replaced with a double pigtail plastic stent.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"José Ramón Aparicio Tormo, MD","CONTACT","(0034)965933468","japariciot@gmail.com",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Pedro López-Muñoz, MD","pedro.lopez8928@gmail.com",[35,59],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Universitario Dr Balmis Alicante","NOT_YET_RECRUITING","Alicante","03010","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],-0.48149,38.34517,{"lat":46,"lon":45},[49,52,54,57],{"name":27,"role":28,"phone":50,"phoneExt":18,"email":51},"0034 965 93 30 00","docenciamedica_hgua@gva.es",{"name":27,"role":53,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":18,"phoneExt":18,"email":18},"Belén Martínez Moreno, MD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":18,"phoneExt":18,"email":18},"Pedro López Muñoz, MD",{"facility":60,"status":61,"city":38,"state":38,"zip":62,"country":40,"countryCode":41,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Hospital General Universitario Dr. Balmis","RECRUITING","03015",{"type":43,"coordinates":64},[45,46],{"lat":46,"lon":45},[67],{"name":68,"role":28,"phone":69,"phoneExt":18,"email":30},"José Aparicio","+34699479179",{"type":53,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jose Ramon Aparicio Tormo","MD","100590452","conservative-versus-proactive-management-of-acute-cholecystitis-after-eus-guided-transmural-gallbladder-drainage-fugitive-trial-fugitive-100590452",false,"NCT06967597","Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)","Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage. Multicenter Randomized Clinical Trial: FUGITIVE Trial (FUGITIVE)","FUGITIVE","Inclusion Criteria:\n\n* Patient ≥ 18 years of age\n* Confirmed acute cholecystitis diagnosed according to Tokyo 2018 criteria.\n* Patient unfit for surgery: if meets one or more of the following criteria: age ≥ 80 years, American Society of Anesthesiology (ASA) ≥ III, Charlson Comorbidity Index \\> 5 and\u002For Karnofsky \\\u003C 50, or patient unwilling to undergo surgery.\n* Gallbladder drainage by LAMS stent.\n* Informed Consent signed\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Gastrointestinal surgically modified anatomy preventing endoscopic access to the gallbladder.\n* Technical failure to perform endoscopic ultrasound guided-gallbladder drainage.\n* Moderate or severe ascites.\n* Severe coagulopathy International Normalized Ratio \\>1.5 and\u002For fibrinogen \\\u003C120) or thrombocytopenia (platelets \\\u003C20,000).\n* Patient unable to tolerate sedation or general anesthesia\n* Haemodynamically unstable patient\n* Life expectancy \\\u003C6 months\n* Baseline ECOG ≥4\n* Patient with ongoing malignancy\n* Pregnancy\n* Acute pancreatitis","ALL","18 Years",{"count":84,"type":85},82,"ESTIMATED","INTERVENTIONAL",[88],"NA","Patients with gallbladder inflammation (acute cholecystitis) who cannot undergo surgery due to their fragility and surgical risk require a gallbladder drainage. It has been confirmed in previous studies that the gallbladder drainage from the digestive tract is a better alternative, because it has fewer complications than external (percutaneous) gallbladder drainage. However, there are no known studies that demonstrate whether it is better to maintain this drainage indefinitely, or to carry out periodic revisions of the drainage to progressively remove the stones lodged in the gallbladder and remove the drainage once this has been achieved. In this study we aim to compare the clinical evolution of patients who undergo this gallbladder drainage, dividing them into two groups:\n\n* One group of patients in whom we maintain a metallic prosthesis or stent, which communicates the gallbladder with the stomach, indefinitely in order to always guarantee a drainage of the bile towards the digestive tract, and thus avoid new episodes of cholecystitis.\n* Another group of patients who, one month after having undergone drainage, undergo a new procedure to remove the gallbladder lithiasis, until it is empty and without inflammation and we can remove the metal stent, leaving only a very thin plastic catheter to maintain the fistula and thus the bile continues to flow into the digestive tract. More than one procedure may be required to completely clear the gallbladder.\n\nKnowledge of whether one strategy or the other presents fewer complications in the short, medium and long term is essential to be able to offer the best alternative to our patients.\n\nThe aim of the study is to compare the clinical outcome of these patients who have a definitive drain inserted with those who undergo several procedures to clear the gallbladder until the drain is removed. The rate of complications, the need for re-interventions and hospital admissions, new episodes of acute cholecystitis, quality of life and mortality of both groups over a period of one year are compared.",[91],"Acute Cholecystitis",[93,94,95,96,97],"EUS-guided gallbladder drainage","acute cholecystitis","interventional endoscopic ultrasonography","lumen apposing metal stents","percutaneous cholecystostomy","2025-06-05",{"date":100,"type":101},"2025-06-10","ACTUAL",{"date":103,"type":101},"2025-06-01",{"date":105,"type":85},"2027-06-01",{"name":5,"class":6},2]