[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital General Universitario de Alicante\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,72,101],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},82,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Acute Cholecystitis",[29,30,31,32,33],"EUS-guided gallbladder drainage","acute cholecystitis","interventional endoscopic ultrasonography","lumen apposing metal stents","percutaneous cholecystostomy","RECRUITING","2025-06-05",{"date":37,"type":38},"2025-06-10","ACTUAL",{"date":40,"type":38},"2025-06-01",{"date":42,"type":21},"2027-06-01",{"name":44,"class":45},"Hospital General Universitario de Alicante","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100585200","sparobopan-project-spanish-registry-of-robotic-pancreatic-surgery-100585200","NCT06899269","SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)","Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)","SPAROBOPAN","Inclusion Criteria:\n\n* robotic pancreatic resections\n* Asa I-III\n* Signed informed consent\n\nExclusion Criteria:\n\n* Less than 18 years old.\n* ASA IV",{"count":56,"type":21},225,"3 Years","OBSERVATIONAL","Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.\n\nMethodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.\n\nAll adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.",[61,62],"Robotic Surgical Procedures","Pancreatic Diseases","NOT_YET_RECRUITING","2025-03-21",{"date":66,"type":38},"2025-03-27",{"date":68,"type":21},"2025-04-01",{"date":70,"type":21},"2029-06-30",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"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":81,"type":21},332,[83],"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.",[86],"Acute Pancreatitis Due to Gallstones",[88,89,90,91],"Acute pancreatitis","Gallstones","Ursodeoxycholic Acid","Randomized Controlled Trial","2025-03-16",{"date":94,"type":38},"2025-03-20",{"date":96,"type":38},"2021-11-10",{"date":98,"type":21},"2027-07-01",{"name":44,"class":45},18,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100543106","effect-of-the-autonomic-nervous-system-on-the-outcomes-of-pulsed-field-ablation-to-treat-atrial-fibrillation-100543106","NCT06351553","Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation","Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation (EASy-PULSE AF)","EASy-PULSE AF","Inclusion Criteria:\n\n\\- Patients with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with permanent atrial fibrillation.\n* Patients with previous pulmonary vein isolation procedure.\n* Patients with pacemakers, or with a diagnosis of atrioventricular block or sinus dysfunction.\n* Patients who show their refusal to participate in the registry, or are unable to understand the informed consent.\n* Patients under 18 years of age.\n* Pregnant.",{"count":110,"type":21},156,[24],"Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.\n\nThe investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA.",[114],"Atrial Fibrillation",[114,116,117],"Pulmonary Vein Isolation","Pulsed Field Ablation","2024-04-01",{"date":120,"type":38},"2024-04-08",{"date":122,"type":21},"2024-06",{"date":124,"type":21},"2026-06",{"name":44,"class":45},1,""]