[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuro-endocrine-tumours\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuro-endocrine-tumours":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100613159","phase-4-preventing-postoperative-complications-in-patients-undergoing-high-risk-pancreatoduodenectomy-with-a-bundle-approach-including-hydrocortisone-octreotide-and-the-teres-ligament-patch-panenca-100613159",false,"NCT07262957","Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)","Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA): an International Randomized Controlled Multicenter Trial","PANENCA","Inclusion Criteria:\n\n* Elective pancreatoduodenectomy for any indication (both minimally invasive and open)\n* Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\\*\n* 18 years of age or older\n* Signature of informed consent\n* In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications, warnings, and precautions as listed in the respective SmPCs\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or current breastfeeding\n* Known allergy or hypersensitivity to hydrocortisone or octreotide\n* Systemic fungal infection\n* Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))\n\n  * Inhibitors must be discontinued ≥7 days before randomization\n  * Inducers must be discontinued ≥28 days before randomization","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The PANENCA trial aims to reduce postoperative complications in patients undergoing pancreatoduodenectomy (also known as a Whipple procedure), a complex surgical operation performed to remove tumors located in or near the head of the pancreas. One of the most frequent and serious complications after this surgery is postoperative pancreatic fistula (POPF), a leakage of pancreatic fluid from the surgical connection. POPF can lead to intra-abdominal infection, bleeding, and inflammation, often resulting in delayed recovery and postponement of subsequent oncological treatment. In severe cases, these complications may be life-threatening.\n\nPatients with a small main pancreatic duct (3 millimeters or less) are known to have a substantially higher risk of developing POPF. Previous studies have shown that several existing interventions may reduce the risk or severity of these complications. These include hydrocortisone, a medication that suppresses postoperative inflammation; octreotide, a medication that reduces the production of pancreatic secretions; and a surgical technique known as the ligamentum teres hepatis patch, which uses the patient's own tissue to protect nearby blood vessels in the event of a pancreatic leak.\n\nBecause the development of pancreatic fistulas is multifactorial, the investigators hypothesize that a combined approach targeting different underlying mechanisms may provide a complementary and more effective protective effect than any single intervention alone. The PANENCA trial therefore evaluates whether the combined use of hydrocortisone, octreotide, and the ligamentum teres patch can reduce the rate of major postoperative complications after pancreatoduodenectomy.\n\nPatients participating in the study are randomly assigned to receive either the combination treatment in addition to standard perioperative care or standard perioperative care alone. The study medications are administered only during the first postoperative days, and the surgical patch is applied during the operation itself. No additional tests, monitoring procedures, or hospital visits are required beyond routine clinical care.\n\nThis international, multicenter randomized trial includes patients at high risk for POPF who are undergoing pancreatoduodenectomy. The primary objective is to determine whether the combination treatment reduces the incidence of major postoperative complications. If proven effective, this bundle approach may be implemented more consistently across participating countries and incorporated into international clinical guidelines for pancreatic surgery.",[27,28,29,30,31,32,33,34,35,36],"Pancreas Head Cancer","Pancreas Adenocarcinoma","IPMN, Pancreatic","Cholangio Carcinoma","Ampulla of Vater Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Duodenal Carcinoma","Mucinous Cystic Neoplasm","Neuro Endocrine Tumours","Pancreatitis",[38,39,40,41,42,43,44,45,46],"Whipple","Pancreatoduodenectomy","POPF","Major complications","Fistula","ISGPS","Hydrocortisone","Octreotide","Ligament teres patch","RECRUITING","2025-12-16",{"date":50,"type":51},"2025-12-22","ACTUAL",{"date":53,"type":51},"2025-09-01",{"date":55,"type":21},"2027-12-01",{"name":57,"class":58},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":85,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":59},"100580294","high-resolution-pet-ct-specimen-imaging-for-the-perioperative-visualization-of-resection-margins-100580294","NCT06835426","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins","High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study","A. Inclusion Criteria:\n\n* able to understand treatment protocol and informed consent form\n* estimated by the investigator to be compliant for study participation\n\n  1\\. Fulfilling all group-specific inclusion criteria:\n* confirmed breast cancer with an indication to undergo breast conserving surgery\n* confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;\n* confirmed thyroid lesion with an indication to undergo resective surgery;\n* confirmed parathyroid adenoma with an indication to undergo resective surgery;\n* suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery;\n* suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery;\n* suspected lesion in the head \\& neck region with an indication to undergo resective surgery;\n* confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery;\n* patients undergoing biopsy after metabolic active lesions were detected on a PET scan.\n* suspected neuro-endocrine malignancies with an indication to undergo resective surgery.\n* suspected brain tumor with an indication to undergo resective surgery.\n* Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery.\n* suspected malignant thoracovascular lesions with an indication to undergo resective surgery\n\nB. Exclusion Criteria:\n\n* general or local contra-indications for resective surgery;\n* in case of FDG-based PET tracers: a blood glucose level over 200 mg\u002FdL on the day of surgery;\n* pregnancy or lactation;\n* participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.",{"count":68,"type":21},150,[70],"NA","These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this.\n\nPositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner.\n\nThe overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.",[73,74,75,76,77,78,79,80,81,35,82,83,84],"Breast Carcinoma","Prostate Cancer Surgery","Thyroid Cancer","Parathyroid Adenomas","Skin Cancer","Genitourinary Cancer","Head and Neck Cancer","Hepatobiliary Cancers","Metabolic Abnormality","Brain Tumours","Gastro Intestinal Cancer","Thoracoscopic Surgery",[86,87,88,89,90,91,92,93,94,95],"resective surgery","perioperative high-resolution PET-CT specimen imaging","breast cancer","Prostate cancer","thyroid cancer","parathyroid cancer","head and neck cancer","neuro-endocrine malignancies","genitourinary malignacies","thoracovascular malignancies","2025-02-14",{"date":98,"type":51},"2025-02-19",{"date":100,"type":51},"2023-08-06",{"date":102,"type":21},"2027-06-30",{"name":104,"class":58},"Algemeen Ziekenhuis Maria Middelares"]