[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-pancreatitis-due-to-gallstones\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-pancreatitis-due-to-gallstones":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100641844","eus-guided-gallbladder-drainage-versus-conservative-management-in-patients-unfit-for-surgery-after-a-biliary-event-without-cholecystitis-drecon-study-100641844",false,"NCT07655778","EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study","Multicenter Comparative Clinical Trial: EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study: (DRainage, Endoscopic Ultrasound, CONservative)","DRECON","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Patients who have experienced a benign biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis) and are candidates for elective cholecystectomy\n* Patients deemed unfuit for surgery (age ≥ 80 years, ASA score ≥ 3, Charlson Comorbidity Index ≥ 5) or who voluntarily refuse surgery\n* Diagnosis of lithogenic\u002Flithiasic material in the gallbladder by imaging (biliary sludge, microlithiasis, and\u002For cholelithiasis)\n* Signed informed consent\n\nExclusion Criteria:\n\n* No signed informed consent\n* Prior cholecystectomy\n* Biliary event secondary to malignant etiology\n* Acute cholecystitis diagnosed according to Tokyo 2018 criteria\n* Moderate-to-severe ascites without prior paracentesis\n* Perforated gallbladder\n* Severe coagulopathy (INR \\> 1.5) or thrombocytopenia (platelets \\\u003C 50,000\u002FμL) not correctable\n* Any clinical condition preventing sedation\n* Patient dependent for daily activities (ECOG ≥ 4)","ALL","18 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cholecystectomy is considered the standard definitive treatment after an acute biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis). However, in elderly patients and\u002For those with significant comorbidities, surgery is often not feasible, leaving this population at high risk of biliary event recurrence (approximately 25-31% per year without treatment).\n\nEUS-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) is an established endoscopic technique currently recommended for acute cholecystitis in patients unfit for surgery. It creates an internal fistula between the gallbladder and the adjacent digestive tract, allowing direct endoscopic access for stone clearance (cholecystoscopy). This approach could theoretically prevent biliary event recurrence similarly to cholecystectomy.\n\nThe DRECON study (DRainaige, Endoscopic ultrasound, CONservative) is a multicenter, randomized, comparative clinical trial evaluating whether EUS-GBD with LAMS reduces biliary recurrence at 1 year compared to conservative managment (CM) in patients unfit for surgery after a biliary event without acute cholecystitis who are candidates for elective cholecystectomy.\n\nPrimary hypothesis: EUS-GBD will reduce the risk of biliary event recurrence (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) at 1 year of follow-up compared to conservative management in patients unfit for surgery with gallbladder lithiasis.\n\nEstimated sample: 110 patients (55 per arm). Randomization 1:1 (EUS-GBD vs CM), stratified by centre and prior biliary sphincterotomy. Duration: 24 months recruitment + 12 months follow-up (total 3 years).\n\nParticipating centres: Hospital Universitari Mútua de Terrassa (coordinating centre), Hospital Universitari de Bellvitge, Hospital General de Granollers, Hospital Universitari Parc Taulí de Sabadell, Hospital Universitari de la Santa Creu i Sant Pau, Hospital Clínico Universitario de Valencia, Hospital General Universitario Dr Balmis and Complexo Hospitalario Universitario de A Coruña.",[27,28,29,30,31,32,33,34],"Cholecystectomy","Gallbladder","Endoscopic Ultrasound (EUS)","Cholelithiasis","Acute Pancreatitis Due to Common Bile Duct Calculus","Biliary Colic","Acute Pancreatitis Due to Gallstones","Cholangitis; Choledocholithiasis",[36,37,38,39,40,29],"gallbladder","gallblader drainage","conservative treatment","biliary recurrence","cholecystectomy","NOT_YET_RECRUITING","2026-06-17",{"date":44,"type":45},"2026-06-22","ACTUAL",{"date":47,"type":21},"2026-07-01",{"date":49,"type":21},"2029-07-01",{"name":51,"class":52},"Hospital Mutua de Terrassa","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100433495","phase-3-ursodeoxycolic-acid-for-the-prevention-of-relapsing-complications-after-gallstone-acute-pancreatitis-100433495","NCT04924868","Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis","Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial","OSOPOLAR","Inclusion Criteria:\n\n* 18 years old or older\n* Hospital admission due to acute pancreatitis (definition: at least 2 of the following criteria: A) Typical pancreatitis pain, B) Amylase and\u002For lipase higher than 3 times the upper level of normality, C) Imaging compatible with acute pancreatitis\n* Presence of gallstones according to any imaging technique\n* Patient informed consent\n\nExclusion Criteria:\n\n* Cholecystectomy and\u002For endoscopic retrograde cholangio-pancreatography and \u002F or endoscopic cholecystostomy prior to recruitment\n* Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)\n* Current waiting list for cholecystectomy for acute biliary pancreatitis at that center less than 30 days\n* Randomization more than 3 days after hospital discharge for acute pancreatitis\n* Ursodeoxycholic acid (UDCA) consumption in the last 5 years or previous UDCA failure to dissolve lithiasis\n* Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with active gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation)\n* Presence of choledocholithiasis diagnosed by imaging tests prior to randomization\n* Active alcoholism greater than or equal to 5 daily alcoholic drinks in men or 3 in women or high clinical suspicion of clinically significant alcoholism\n* Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult\n* Hypertriglyceridemia greater than 400 mg \u002F dL during admission or history of poorly controlled severe hypertriglyceridemia\n* Chronic pancreatitis (pancreatic calcifications and \u002F or Wirsung duct 4 or more mm)\n* Pancreatic cystic lesions not attributed to the pancreatitis itself\n* Wirsung duct stenosis\n* Primary hyperparathyroidism\n* Pregnancy",{"count":62,"type":21},332,[64],"PHASE3","Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and anger for patients affected by these complications on the waiting list, damaging their relationship with the health system and it is linked to increased cost. In addition, there is a very vulnerable group, those patients who due to age or serious diseases cannot undergo gallbladder surgery but have a high probability of suffering biliary problems due to the stones they have.\n\nUrsodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately so it is not frequently used. Our objective is to investigate if UDCA is useful in this scenario, which would avoid suffering and adverse consequences for the patient and reduce the consumption of resources.",[33],[68,69,70,71],"Acute pancreatitis","Gallstones","Ursodeoxycholic Acid","Randomized Controlled Trial","RECRUITING","2025-03-16",{"date":75,"type":45},"2025-03-20",{"date":77,"type":45},"2021-11-10",{"date":79,"type":21},"2027-07-01",{"name":81,"class":52},"Hospital General Universitario de Alicante",18]