[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356476":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":59,"collaborators":62,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hospital del Rio Hortega","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ERCP with sphincterotomy + gall bladder drainage with LAMS","EXPERIMENTAL","An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. After this, transmural drainage of the gallbladder will be performed by placing a LAMS Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL will be placed on it to generate the anastomosis between the aforementioned structures.",[13],"Procedure: Gall bladder transmural drainage with LAMS",{"label":15,"type":16,"description":17,"interventionNames":18},"ERCP with sphincterotomy","ACTIVE_COMPARATOR","An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Gall bladder transmural drainage with LAMS","Placing a PAL Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL 15x10 mm or 10x10 mm will be \\*placed on it to generate the anastomosis between the aforementioned structures.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Ana Y Carbajo López, MD","Hospital Río Hortega","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Marina de Benito Sanz, MD","CONTACT","983420400","84326","mbenitosa@saludcastillayleon.es",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Manuel Pérez-Miranda Castillo, MD, PhD","84408","mperezmiranda@saludcastillayleon.es",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hospital Rio Hortega","RECRUITING","Valladolid","47012","Spain","ES",{"type":51,"coordinates":52},"Point",[53,54],-4.72353,41.65541,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":25,"phoneExt":25,"email":25},"Marina De Benito, MD",{"type":30,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Marina de Benito Sanz","Principal investigator",[63,65],{"name":64,"class":6},"Hospital Universitario Ramon y Cajal",{"name":66,"class":6},"Hospital General Universitario de Alicante","100356476","clinical-trial-comparing-ercp-vs-ercp-and-transmural-gall-bladder-drainage-100356476",false,"NCT03921502","Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage","Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis","PECAS","Inclusion Criteria:\n\n* Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or obstructive jaundice), analytical and imaging according to the criteria of high probability of choledocholithiasis established in the clinical guidelines (ASGE Guide).\n* Discarded for surgical treatment due to age, comorbidity or refusal of the patient.\n* Age\\>75 years\n\nExclusion Criteria:\n\n* Charlson comorbidity scale adjusted to age \\\u003C4.\n* Hepatobiliary surgery or previous superior digestive tract.\n* Ascitis.\n* Inability to tolerate sedation of endoscopy, perforation of the digestive tract or other contraindication to endoscopy.\n* Coagulopathy with INR (international normalized ratio) \\> 1.5 not correctable or thrombocytopenia \\\u003C50000 \u002F mm3 not correctable.\n* Other diagnoses at admission (acute cholecystitis, acute pancreatitis, biliopancreatic neoplasia).\n* Hemodynamic instability.\n* Urgent procedure performed after hours\n* No availability of expert material \u002F endoscopist in drainage.\n* Anatomical impossibility of performing biliary drainage (absence of vesicular distension, contact between gallbladder and stomach or duodenum, contact area \\\u003C10 mm).\n* Baseline ECOG (Easthern Cooperative Oncology Group) \\> = 4\n* Expectancy of survival \\\u003C6 months.\n* Refusal to participate.\n* Distance between the gallbladder and upper digestive tract\\> 1cm, scleroatrophic vesicle, lack of stable acoustic window for drainage\n* ERCP failed (inhability to dain common bile duct)","ALL","75 Years",{"count":78,"type":79},150,"ESTIMATED","INTERVENTIONAL",[82],"NA","Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence.\n\nThe investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications.\n\nThe study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.",[85,86],"Bile Duct; Obstruction, With Calculus","Choledocholithiasis",[86,88,89],"Gall Bladder drainage","LAMS","2025-03-10",{"date":92,"type":93},"2025-03-11","ACTUAL",{"date":95,"type":93},"2019-08-01",{"date":97,"type":79},"2026-05-01",{"name":5,"class":6},1]