[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampullary-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampullary-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100627277","effect-of-negative-pressure-drainage-versus-pancreatic-duct-stenting-for-preventing-pancreatitis-after-endoscopic-papillectomy-for-duodenal-papillary-tumors-100627277",false,"NCT07446543","Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors","Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 75 years\n2. Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)\n3. Scheduled to undergo endoscopic papillectomy\n\nExclusion Criteria:\n\n1. Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.\n2. Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.\n3. Lesion diameter \\>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.\n4. Known familial adenomatous polyposis (FAP).\n5. Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.\n6. Coagulopathy or bleeding disorders.\n7. Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.",[27,28,29],"Ampulla of Vater Neoplasms","Ampullary Adenoma","Ampullary Carcinoma",[31,32,33,34,35],"endoscopic papillectomy","ampullary tumor","negative-pressure drainage","pancreatic duct stent","randomized controlled trial","NOT_YET_RECRUITING","2026-03-03",{"date":39,"type":40},"2026-03-04","ACTUAL",{"date":42,"type":21},"2026-03-20",{"date":44,"type":21},"2029-06-30",{"name":46,"class":47},"Cui Xiaobing","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100618206","outcomes-after-laparoscopic-versus-open-pancreaticoduodenectomy-100618206","NCT07328607","Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy","Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .\n* Resectable disease based on preoperative imaging.\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.\n* American Society of Anesthesiologists(ASA )classification I-III.\n* Patients able to provide informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Previous pancreatic surgery.\n* Concurrent major abdominal procedures .\n* ASA classification IV or higher.\n* Metastatic disease identified preoperatively.\n* Locally advanced unresectable disease.\n* Active infection or sepsis at time of surgery.\n* Severe cardiopulmonary comorbidities precluding major surgery.\n* Pregnancy.\n* Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .",{"count":56,"type":21},90,[24],"This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.",[60,29,61,62,63],"Pancreatic Ductal Adenocarcinoma","Distal Cholangiocarcinoma","Duodenal Adenocarcinoma","Pancreatic Neuroendocrine Tumor","RECRUITING","2026-01-17",{"date":67,"type":40},"2026-01-21",{"date":65,"type":40},{"date":70,"type":21},"2028-04-15",{"name":72,"class":47},"Minia University",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100520893","phase-2-surufatinib-combined-with-toripalimab-and-ag-regiments-for-first-line-treatment-of-unresectable-or-relapsing-metastatic-ampullary-carcinoma-100520893","NCT06062485","Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma","Efficacy and Safety of Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma","Inclusion Criteria:\n\n1. Over 18 years old;\n2. Unresectable or relapses metastatic ampullary malignancies identified by histopathology or cytology,with histological subtypes of parenteral type;\n3. Have not received systematic treatment for unresectable or metastatic ampulla malignant tumor;A scheme of adjuvant or neoadjuvant chemotherapy and 6 months after the chemotherapy recurrence can into the group;\n4. ECOG score 0 or 1;\n5. Expected survival≥12 weeks;\n6. Have at least one measurable lesion;\n7. Major organ functions within 7 days prior to treatment shall meet the following criteria:\n\n(1)Hemoglobin(HB)≥90 g\u002FL; (2)neutrophil absolute value(ANC)≥1.5×109\u002FL; (3)Platelet(PLT)≥100×109\u002FL;\n\n8.Biochemical examination shall meet the following standards:\n\n1. Total bilirubin(TBIL)≤3 times the upper limit of normal value(ULN);\n2. ALT and aspartate aminotransferase AST≤2.5×ULN,and ALT and AST≤5×ULN with liver metastasis;\n3. Serum creatinine(Cr)≤1.5×ULN or creatinine clearance(CCr)≥60ml\u002Fmin;\n\n9.Doppler ultrasound evaluation:left ventricular ejection fraction(LVEF)≥the lower limit of normal value(50%)；\n\n10.Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;\n\n11.Subjects voluntarily joined the study and signed an informed consent form(ICF);\n\n12.It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements.\n\nExclusion Criteria:\n\n1. Patients who have previously been treated with small-molecule drugs similar to VEGFR-TKI,such as Anlotinib,Sunitinib,Sorafenib,Lenvatinib,Apatinib,etc.\n2. Anti-pd-1 or anti-PD-L1\u002FL2 antibodies or anti-cytotoxic T lymphocyte-associated antigen(CTLA-4)antibodies were used in the past;\n3. Malignant ampulla obstruction after clinical intervention was not resolved or anti-infective therapy was required 14 days before the first study of drug therapy;\n4. Patients with severe allergic history or allergic constitution;\n5. Pregnant or lactating women;\n6. Patients who have participated in other clinical trials and have not terminated the trials;\n7. Patients with any severe and\u002For uncontrolled medical condition,including:\n\n(1)Patients with unsatisfactory blood pressure control(systolic blood pressure≥150 mmHg,diastolic blood pressure≥100 mmHg); (2)Patients with grade I or above myocardial ischemia or myocardial infarction,arrhythmias(including QTc≥480ms),and≥grade 2 congestive heart failure(New York Heart Association(NYHA)grades); (3)Active or uncontrolled severe infection(≥CTC AE grade 2 infection); (4)Cirrhosis,decompensated liver disease,active hepatitis or chronic hepatitis require antiviral therapy; (5)Renal failure requiring hemodialysis or peritoneal dialysis; (6)A history of immunodeficiency,including HIV positive or other acquired or congenital immunodeficiency diseases,or a history of organ transplantation; (7)Urine protein≥++was indicated by two consecutive urine routine,and the 24-hour urine protein quantity was confirmed to be\\>1.0 g; (8)Mental illness,including epilepsy,dementia,severe depression,mania,etc.\n\n8.Received major surgical treatment,open biopsy,or significant traumatic injury within 28 days prior to grouping(specifically in conjunction with clinical evaluation);\n\n9.History of any active autoimmune disease or autoimmune disease,including but not limited to interstitial pneumonia,uveitis,inflammatory bowel disease,hepatitis,pituitary inflammation,vasculitis,systemic lupus erythematosus,etc.;\n\n10.The patient currently has active gastric and duodenal ulcers,ulcerative colitis and other digestive diseases,or active bleeding from unexcised tumors,or other conditions determined by researchers that may cause gastrointestinal bleeding and perforation;\n\n11.Patients with any physical signs or history of bleeding,regardless of severity;Unhealed wounds,ulcers,or fractures were observed in patients with any bleeding or bleeding events≥CTCAE grade 3 during the first 4 weeks of enrollment;\n\n12.Experienced arteriovenous thrombotic events,such as cerebrovascular accidents(including temporary ischemic attacks),deep vein thrombosis and pulmonary embolism,within 6 months;\n\n13.Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;\n\n14.Subjects with dysphagia or known drug absorption disorders.\n\n15.The researchers considered other conditions unsuitable for inclusion.",{"count":82,"type":21},30,[84],"PHASE2","A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.",[29],"2023-09-29",{"date":89,"type":40},"2023-10-02",{"date":91,"type":21},"2023-10",{"date":93,"type":21},"2026-10",{"name":95,"class":47},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"]