[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatoduodenectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatoduodenectomy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,78,107,135,160,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100589344","intraoperative-hypotension-in-pancreatoduodenectomy-a-randomized-trial-of-general-versus-combined-anesthesia-100589344",false,"NCT06953193","Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia","Inclusion Criteria:\n\n* Signed written informed consent.\n* Patients scheduled for elective pancreatoduodenectomy at National Institute of Medical Sciences and Nutrition Salvador Zubirán.\n* No contraindications for neuroaxial anesthesia (epidural catheter placement), including:\n\n  * Generalized or localized infection at the puncture site.\n  * Thrombocytopenia.\n  * Coagulation disorders.\n  * Intracranial hypertension.\n  * Patient refusal.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Pregnancy.\n* Inability to randomize the case due to specific circumstances (such as contraindications to epidural use), resulting in non-eligibility based on participation criteria.","ALL","18 Years",{"count":18,"type":19},206,"ESTIMATED","INTERVENTIONAL",[22],"NA","This randomized clinical trial compares the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. The primary aim is to assess the incidence of intraoperative hypotension and related adverse events. Secondary outcomes includes vasopressor requirements, transfusion needs, postoperative complications, intensive care unit admission, hospital length of stay, and mortality.",[25,26,27],"Pancreatic Neoplasms","Hypotension","Pancreatoduodenectomy",[29,30,31,32,33,34],"Pancreatic Surgery","General Anesthesia","Hemodynamic Changes","Vasopressors","Postoperative Complications","Combined Anesthesia","RECRUITING","2026-03-27",{"date":38,"type":39},"2026-04-01","ACTUAL",{"date":41,"type":39},"2025-04-07",{"date":43,"type":19},"2030-04-30",{"name":45,"class":46},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100625516","phase-4-continous-infusion-of-nefopam-for-patients-undergoing-pancreatoduodenectomy-100625516","NCT07423650","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy","Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial","Inclusion Criteria:\n\n1. Patients scheduled for elective pancreatoduodenectomy surgery\n2. Agreed to participate in the study\n\nExclusion Criteria:\n\n1. Refusal to participate\n2. Emergency surgery\n3. Patients with neurological disorders or other muscular or psychiatric disorders that impede communication\n4. Known allergic reactions to the used medication\n5. Known hyperalgesia\n6. Chronic opioid consumption\n7. Patients that require reintervention in the first 48h postoperatively\n8. Patients with pancreaticogastrostomy","80 Years",{"count":57,"type":19},93,[59],"PHASE4","The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.\n\nThe main questions are:\n\nDoes nefopam administration reduce opioid consumption after pancreatoduodenectomy?\n\nDoes nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?\n\nResearchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.\n\nParticipants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.",[27,62,63,64],"Pain Management","Opioid Analgesia","Multimodal Analgesia",[66,27,67,68],"Nefopam","Opioids","Multimodal analgesia","2026-03-19",{"date":71,"type":39},"2026-03-24",{"date":73,"type":19},"2026-03",{"date":75,"type":19},"2026-10",{"name":77,"class":46},"Iuliu Hatieganu University of Medicine and Pharmacy",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":20,"phases":88,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"100625397","pan-clo-bu-pancreas-clostridium-butyricum-100625397","NCT07422103","PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)","Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study","PAN-CLO-BU","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Patients undergoing pancreaticoduodenectomy\n* Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy\n* Patients with benign or malignant periampullary neoplasms\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Previous or current use of Clostridium butyricum CBM588\n* Lactose intolerance\n* Neoadjuvant chemotherapy or radiotherapy",{"count":87,"type":19},158,[22],"This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.",[91,92,93,94,27,95],"Pancreatic Cancer","Pancreatic Diseases","Gastrointestinal Symptoms","Clostridium Butyricum Miyairi","CBM588",[91,92,93,94],"NOT_YET_RECRUITING","2026-02-12",{"date":100,"type":39},"2026-02-19",{"date":102,"type":19},"2026-03-15",{"date":104,"type":19},"2030-11-30",{"name":106,"class":46},"Casa di Cura Dott. Pederzoli",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":20,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100617428","antiseptic-coated-sutures-and-pancreatic-fistula-risk-after-pancreatoduodenectomy-100617428","NCT07318493","Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy","Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial","Triclosan","Inclusion Criteria:\n\n* Subjects must be undergoing a scheduled pancreatoduodenectomy.\n* Age ≥18 years.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years old\n* Patients who are pregnant\n* Patients with history of previous pancreatic surgery\n* Patients who are unable to provide informed consent",{"count":116,"type":19},436,[22],"The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.",[27,120],"Whipple Procedure",[122,123,124],"pancreatoduodenectomy","whipple procedure","sutures","2026-01-19",{"date":127,"type":39},"2026-01-21",{"date":129,"type":39},"2026-01-13",{"date":131,"type":19},"2031-02",{"name":133,"class":46},"The Cleveland Clinic",3,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":47},"100540662","characteristics-of-intestinal-microbiome-following-pancreatic-surgery-100540662","NCT06319755","Characteristics of Intestinal Microbiome Following Pancreatic Surgery","Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study","Inclusion Criteria:\n\n* Adults (aged equal to or greater than 18 years) having had pancreatoduodenectomy (Whipple's) surgery between April 2018 - December 2023 for curative intent and received post-operative clinical management at Royal Prince Alfred Hospital, (post-surgical participants), and\n* Healthy adults matched by age, sex, body mass index and smoking status\n\nExclusion Criteria:\n\n* Aged less than 18 years\n* Are unable to complete the questionnaires or testing due to language or cognitive limitations\n* Have active or recurring pancreatic cancer, or where the surgery was for non-curative intent\n* Have other gastrointestinal conditions that could affect gut symptoms or microbiome such as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or are currently pregnant or breastfeeding\n* Are currently taking medications or diet that can affect gut symptoms or microbiome",true,{"count":144,"type":19},20,"OBSERVATIONAL","The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.\n\nThe primary objectives of the study are:\n\n1. To explore and describe any differences in the gut microbiota especially Shannon diversity index\n2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.\n\nParticipants will be asked to complete the following:\n\n* Three-day food, bowel and medication diary (see Protocol appendix 5)\n* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)\n* Quality of life questionnaire (see Protocol appendix 7)\n* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)",[91,148,27],"Microbiota",[150],"matched case control study","2025-07-21",{"date":153,"type":39},"2025-07-24",{"date":155,"type":39},"2024-08-01",{"date":157,"type":19},"2025-08",{"name":159,"class":46},"Royal Prince Alfred Hospital, Sydney, Australia",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":47},"100537848","metabolomic-and-immune-profiling-in-the-development-of-pancreatic-fistulas-after-cephalic-duodenopancreatectomy-100537848","NCT06283160","METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy","Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy","PROMETHEE","Inclusion Criteria:\n\n* patients scheduled to undergo elective pancreaticoduodenectomy\n* Non-opposition of the subject to participate in the study.\n* Affiliated to the French social security system (CMU included).\n\nExclusion Criteria:\n\n* Emergent surgery.\n* Pregnant patients.\n* Refusal to participate or inability to provide informed consent.\n* Patient under legal protection (individuals under guardianship by court order).",{"count":169,"type":19},80,"Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.\n\nThe aim of this prospective monocentric and observational study is to identify predictive biomarkers and\u002For risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.\n\nParticipants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).",[172,173,27],"Pancreatic Fistula","Acute Pancreatitis",[175,176,177,122],"Metabolomics","Immune response","Pancreatic fistula","2024-10-10",{"date":180,"type":39},"2024-10-15",{"date":182,"type":39},"2024-03-01",{"date":184,"type":19},"2026-05-30",{"name":186,"class":46},"Centre Hospitalier Universitaire de Besancon",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":195,"targetDuration":197,"studyType":145,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":47},"100508039","mesopancreas-study-in-pancreatic-cancer-100508039","NCT05895214","Mesopancreas Study in Pancreatic Cancer","MESOPANC-01 Study: The Mesopancreas and the Ductal Adenocarcinoma of the Pancreatic Head: From Preoperative Imaging to Histopathological and Surgical Outcome","MESOPANC-01","Inclusion Criteria:\n\n* All patients age ≥18 years who are admitted for primary surgery or patients who Received neoadjuvant therapy prior to surgery\n* CRM analysis through Pathologic Institute in study centre already implemented (see LEEPP protocol Menon et al (2009) Impact of margin status on survival following pancreatoduodenectomy for cancer: the Leeds Pathology Protocol (LEEPP). HPB 11(1):18-24)\n* Preoperative computed-tomographic Imaging (biphasic) prior to surgery (if resected without neoadjuvant treatment)\n* Pre-chemotherapeutic computed-tomographic and post-chemotherapeutic computed-tomographic if neoadjuvantly treated (biphasic).\n* indepth information of surgical procedure (pancreatic tail preserved:yes\u002Fno, pylorus preserved resection: yes\u002Fno, venous resection: complete\u002Fpartial\u002Fno, arterial resection: complete\u002Fpartial\u002Fno)\n\nExclusion Criteria:\n\n* Palliation\n* Abort of operative procedure\n* No preoperative computed-tomography for staging\n* No pathological CRM Implementation according to the LEEPP",{"count":196,"type":19},500,"24 Months","After the Introduction of the pathological circumferential resection margin (CRM status by LEEPP Protocol), residual cancer (R1 resection) was most often found in the dorsal and medial resection margins. Yet only the medial resection margin is preoperatively evaluated during staging, while the dorsal resection margin which embeds the mesopancreatic fat and thus resembles the area of the mesopancreas, is not considered during preoperative assessment for resectability. Local recurrence is similarly prevalent as systemic relapse, and revised lower rates of R0CRM- resections through the LEEPP protocol explained the poor local tumor control. The aim of this study is to interdisciplinary approach the circumferential infiltration status of the PDAC concentrating foremost on the mesopancreas of the dorsal resection margin by including anatomic and embryologic derived perspectives.",[200,27,201,202,203],"PDAC","Margin, Resection","Surgery","Local Recurrent Tumor","2023-05-30",{"date":206,"type":39},"2023-06-08",{"date":208,"type":19},"2023-06-01",{"date":210,"type":19},"2027-01-01",{"name":212,"class":46},"Heinrich-Heine University, Duesseldorf"]