[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperthermic-intraperitoneal-chemotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperthermic-intraperitoneal-chemotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100543100","efficacy-of-intraoperative-use-of-20-albumin-combined-with-ringer-lactate-versus-ringer-lactate-during-cytoreductive-surgery-with-hyperthermic-intraperitoneal-chemotherapy-100543100",false,"NCT06351475","Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy","Evaluation de l'efficacité du Remplissage Vasculaire Par de l'ALBUmine Humaine 20% + Ringer Lactate comparé au Ringer Lactate Seul Chez Les Patients opérés Par cytoréduction Avec CHimiothérapie Intrapéritonéale hyPerthermique","ALBUCHIP","Inclusion Criteria:\n\n* Male and female patients aged 18 years old and older\n* Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)\n* Patient volunteer for the study and provided written informed consent\n* Patient affiliated to the French Health Insurance\n\nExclusion Criteria:\n\n* Adults \\>75 years old\n* Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG \\> 2 or Karnofsky index \\\u003C 75)\n* Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition)\n* Severe preoperative hypoalbuminemia (albuminemia \\\u003C 20 g\u002FL)\n* History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction \\\u003C 40%)\n* Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions)\n* Significant ascites with preoperative respiratory repercussions\n* Uncontrolled diabetes (HbA1c \\> 8.5%)\n* Allergy to exogenous human albumin and its excipients.\n* Contraindication to the administration of Ringer's lactate (history of allergy)\n* Hyperkalemia \\> 6.0 mmol\u002FL\n* Hypercalcemia (total calcium \\> 2.60 mmol\u002FL)\n* Chronic use of digitalis and hyperkalemic diuretics\n* Pregnancy, breastfeeding\n* Known preoperative renal failure (GFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 or extrarenal purification)\n* Recent brain trauma \\\u003C 6 months (traumatic, ischemic, or hemorrhagic)\n* Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable\n* Patient deprived of liberty\n* Patient under guardianship or curatorship","ALL","18 Years","80 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.\n\nMethods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.\n\nRecruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.\n\nRandomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.\n\nIntervention\n\n* 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL\u002Fkg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g\u002FL). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.\n* Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.\n\nOutcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28\n\nSample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.\n\nDiscussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.",[28,29,30,31,32],"Peritoneal Neoplasms","Hyperthermic Intraperitoneal Chemotherapy","Intraoperative Care","Fluid Therapy","Postoperative Complications",[34,35,36,37,38,39,40],"Cytoreductive surgery","Hyperthermic intraperitoneal chemotherapy","Albumin administration","Fluid therapy","Post operative prognosis","Randomized clinical trial","Open label clinical trial","RECRUITING","2025-11-28",{"date":44,"type":45},"2025-12-05","ACTUAL",{"date":47,"type":45},"2025-09-03",{"date":49,"type":22},"2027-10",{"name":51,"class":52},"Assistance Publique - Hôpitaux de Paris","OTHER",7,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100588860","phase-2-the-safety-and-effectiveness-of-hyperthermic-intraperitoneal-chemotherapy-combined-with-intravenous-chemotherapy-for-peritoneal-metastatic-pancreatic-cancer-a-phase-ii-clinical-trial-100588860","NCT06946901","The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial","Inclusion Criteria:\n\n* Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures;\n* Aged \\>=18 and \\\u003C=80 years, regardless of gender;\n* No contraindications to surgery, with an ECOG performance status of 0-1;\n* Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapid intraoperative histopathology indicating metastatic adenocarcinoma;\n* No prior anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional Chinese medicine anti-tumor treatments;\n* No severe hematological, cardiac, pulmonary dysfunction, or autoimmune deficiency (based on respective diagnostic criteria);\n* Hematological criteria: White blood cells (WBC) \\>=3.0 × 10⁹\u002FL; Absolute neutrophil count (ANC) \\>=1.5 × 10⁹\u002FL; Platelets (PLT) \\>=100 × 10⁹\u002FL; Hemoglobin (Hgb) \\>=90 g\u002FL.\n* Blood biochemistry criteria: AST (SGOT) and ALT (SGPT) \\\u003C=2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) \\\u003C=2 × ULN; Serum creatinine (CRE) \\\u003C=1.5 × ULN.\n* Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) \\\u003C=1.5 × ULN;\n* Compliance with study visit schedules and other protocol requirements.\n\nExclusion Criteria:\n\n* Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;\n* History of other systemic malignancies within the past five years;\n* Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;\n* Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);\n* History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;\n* Pregnancy, autoimmune diseases, severe hyperthyroidism\u002Fhypothyroidism, central nervous system disorders, psychiatric illnesses, unstable angina, congestive heart failure, severe arrhythmias, or other uncontrolled serious medical conditions;\n* History of hypersensitivity to the study drugs or medications with similar chemical structures;\n* Patients requiring long-term warfarin anticoagulation therapy;\n* Poor compliance, inability or unwillingness to provide signed informed consent;\n* Patients likely to be lost to follow-up for ≥14 days during the treatment period.",{"count":61,"type":22},90,[63],"PHASE2","The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. The main question it aims to answer are:\n\n(1) Does this combined approach increase 1-year survival rates? and (2) What is the safety profile of this treatment regimen?\n\nParticipants will:\n\nundergo baseline imaging and surgical exploration to confirm peritoneal metastasis, receive two cycles of intraperitoneal cisplatin HIPEC (70mg\u002Fm²) postoperatively, followed by systemic AG chemotherapy (nab-paclitaxel plus gemcitabine), with treatment adjustments based on regular imaging assessments and multidisciplinary team (MDT) recommendations.",[29,66],"Peritoneal Metastatic Pancreatic Cancer","2025-04-19",{"date":69,"type":45},"2025-04-27",{"date":71,"type":45},"2025-04-03",{"date":73,"type":22},"2027-12-31",{"name":75,"class":52},"Shanghai Zhongshan Hospital"]