[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-stones\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-stones":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100418936","prophylactic-cholecystectomy-in-midgut-nets-patients-who-require-primary-tumor-surgery-100418936",false,"NCT04735198","Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.","Effectiveness of Prophylactic Cholecystectomy in Patients With Midgut Neuroendocrine Tumor (Jejunum, Ileum or Proximal Colon) Who Require Primary Tumor Surgery. Randomized, Proof of Concept Clinical Trial.","TNE-IDC-COLE","Inclusion Criteria:\n\n* Patients must grant the informed consent written, signed and dated.\n* Male or female older than 18 years old.\n* Radiological or histological diagnose of midgut NET that can be treated with surgery.\n* In case of female with childbearing age (time between menarche and menopause), a pregnancy test with negative result.\n* Neuroendocrine tumors located in any of the aforementioned locations.\n* Presence or not of distant metastasis.\n* Presencié or not of gallstones.\n* Capacity of follow up.\n\nExclusion Criteria:\n\n* Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).\n* Patients that have gone through a previous bowel resection.\n* Patients with previous cholecystectomy.\n* Pacients with biliary stone disease.\n* Patients who are candidate to liver resection or liver transplant.\n* Patients with a gallbladder polyp bigger than 6 mm.\n* Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp.\n* Refusal to participate.\n* Patients with previous history of malignant neoplasms in the last 5 years, except skin basal cell carcinoma, \"in situ\" cervical carcinoma or in situ carcinoma found in a polyp removed with a colonoscopy.\n* Medical criteria that doesn't consider the patient a candidate to participate in the study.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms.\n\nThe idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors.\n\nIt's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy.\n\nOur hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.",[27,28],"Midgut Carcinoid Tumor","Biliary Stones",[30,31,32],"Neuroendocrine tumor","prophylactic cholecystectomy","Biliary stone disease","RECRUITING","2025-05-15",{"date":36,"type":37},"2025-05-20","ACTUAL",{"date":39,"type":37},"2021-01-20",{"date":41,"type":21},"2026-02-28",{"name":43,"class":44},"Hospital Universitari de Bellvitge","OTHER",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100304513","spyglass-ds-peroral-cholangioscope-guided-ll-or-ehl-versus-bml-for-endoscopic-removal-of-complicated-bile-duct-stones-100304513","NCT03244163","Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones","Randomized Controlled Trial of Spyglass DS Peroral Cholangioscope Guided Laser Lithotripsy or Electrohydraulic Lithotripsy Versus Conventional Basket Mechanical Lithotripsy for Endoscopic Removal of Complicated Bile Duct Stones","Inclusion Criteria:\n\n* Patients with complicated biliary stones\n* Patients older than 18 years old\n* Patients where informed consent can be obtained\n\nExclusion Criteria:\n\n* Patients who cannot give informed consent\n* Patients under 18 years old\n* Pregnant or lactating patients\n* Patient with altered gastrointestinal\u002Fbiliary anatomy\n* Patients with distal CBD malignant stricture from intrinsic or extrinsic causes\n* Patients with ongoing cholangitis or biliary pancreatitis\n* Patient with refractory bleeding tendencies (Platelet count \\\u003C50,000\u002Fmm3 or International Normalized Ratio \\>1.5 despite correction with platelet or fresh frozen plasma transfusions)\n* Patients with intrahepatic segmental stones\n* Patients with contraindications to endoscopy due to comorbidities","99 Years",{"count":55,"type":21},86,[24],"This study aims to compare the overall rate of endoscopic clearance of complicated bile duct stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser\u002Felectrohydraulic lithotripsy versus conventional BML.",[28],[60,61,62],"Spyglass DS","Laser lithotripsy","Endoscopic retrograde cholangiopancreatography","2024-09-01",{"date":65,"type":37},"2024-09-04",{"date":67,"type":37},"2016-06-14",{"date":69,"type":21},"2026-12",{"name":71,"class":44},"Chinese University of Hong Kong",1]