[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jon Unosson\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100496437","phase-3-improved-recovery-by-iron-following-surgery-with-blood-loss-the-iris-trial-100496437",false,"NCT05744219","Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial","Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)","IRIS","Inclusion Criteria:\n\n1. Provision of written informed consent\n2. Male and female patients\n3. Weight \\> 50 kg\n4. \\> 18 years of age\n5. Scheduled for complex aortic surgery, liver resection or pancreatic resection\n\nExclusion Criteria:\n\n1. Short expected survival (less than six months)\n2. Intra-venous iron therapy within one month prior to surgery\n3. Severe anaemia (B-Hb \\\u003C80 mg\u002FL) prior to surgery\n4. Contraindication to Ferric Carboxymaltose according to SmPC\n5. Iron overloading disorder, i.e. hemochromatosis\n6. Risk of small for size future liver remnant\n7. Pre-operative renal replacement therapy\n8. Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study\n9. Another planned major surgical procedure before the five week follow up\n10. Unsuitable for inclusion according to the investigator\n11. Pregnancy","ALL","18 Years",{"count":20,"type":21},338,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss.\n\nPost-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion.\n\nPatients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study.\n\nBy the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo.\n\nThe primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb \\\u003C80 g\u002FL) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio.\n\nThe trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\\\u003C400 ml), high (400-4000 ml) and very high (\\>4000 ml) per-operative blood loss.\n\nRecruitment will continue until 338 patients are randomized or 304 have completed the five week follow up\n\nThe coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.",[27,28,29,30,31],"Surgery","Liver Metastases","Liver Cancer","Pancreas Cancer","Aortic Aneurysm","RECRUITING","2024-10-17",{"date":35,"type":36},"2024-10-21","ACTUAL",{"date":38,"type":36},"2024-09-04",{"date":40,"type":21},"2028-03-30",{"name":42,"class":43},"Jon Unosson","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100521153","para-aortic-lymph-node-metastasis-in-resectable-pancreatic-cancer-100521153","NCT06065891","Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer","Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study","PALN","Inclusion Criteria:\n\nResectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)\n\nBorderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)\n\nAge \\>18 years\n\nWritten patient consent\n\nExclusion Criteria:\n\nContraindication for a radical resection procedure\n\nUnresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included)\n\nMental or organic disorders which could interfere with giving informed consent or receiving treatments",{"count":54,"type":21},300,[56],"NA","Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned.\n\nThe aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.\n\nPrimary outcome\n\n1\\) To determine incidence of PALN metastasis in patients submitted to a tentative curative resection\n\nSecondary outcomes\n\n1. To determine prognosis of patients with PALN metastasis after a curative resection\n2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.\n3. To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.\n4. To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.\n\n300 patients are planned to be included in the trial.",[30,59,60],"Pancreas Adenocarcinoma","Lymph Node Metastasis","2023-09-26",{"date":63,"type":36},"2023-10-04",{"date":65,"type":36},"2023-09-05",{"date":67,"type":21},"2028-09-05",{"name":42,"class":43},6,""]