[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631543":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":35,"interventions":47,"overallOfficials":25,"centralContacts":25,"locations":55,"responsibleParty":75,"collaborators":25,"id":79,"slug":25,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":25,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":25,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green","Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy, defined as measurable drain output of any volume on or after postoperative day 3, with an amylase content greater than three times the upper limit of normal serum amylase activity.","Within 30 days after surgery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy","Extent of pancreatic resection during pancreaticoduodenectomy, assessed intraoperatively. This includes whether an extended resection beyond the standard procedure was performed (yes\u002Fno).","Surgery day",{"measure":19,"description":20,"timeFrame":21},"Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green","Length of hospital stay, measured as the number of days from surgery to hospital discharge following pancreaticoduodenectomy.","From day of surgery to hospital discharge (up to 30 days)",{"measure":23,"description":24,"timeFrame":12},"30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green","Mortality within 30 days after pancreaticoduodenectomy, defined as death from any cause occurring within 30 days following surgery.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":31,"maskingDescription":25,"whoMasked":32},"DOUBLE",[33,34],"PARTICIPANT","OUTCOMES_ASSESSOR",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Indocyanine Green","EXPERIMENTAL","Once the pancreas has been resected and the specimen is outside, before performing the pancreatic-jejunal anastomosis, ICG will be injected.\n\nA dose of 0.1 mg\u002Fkg of ICG will be used, which is within a safe range. After injecting the ICG, the surgeon will wait for up to 90 seconds to assess if there is hypoperfusion of the pancreatic margin. If hypoperfusion is observed, an extension of the resection will be performed towards the left (normally 1.5 - 2 cm) from the neck of the pancreas, until a well-perfused pancreatic area is reached.\n\nOnce the resection margin has been extended, the pancreatic-jejunal anastomosis will be performed according to the standard technique.",[41],"Procedure: Indocyanine Green",{"label":43,"type":38,"description":44,"interventionNames":45},"No Indocyanine Green","Once the pancreas has been resected and the specimen is outside, we will perform the pancreatic-jejunal anastomosis according to the Blumgart technique and complete the surgery.",[46],"Procedure: No Indocyanine Green",[48,52],{"type":49,"name":43,"description":50,"armGroupLabels":51,"otherNames":25},"PROCEDURE","No ICG injection",[43],{"type":49,"name":37,"description":53,"armGroupLabels":54,"otherNames":25},"ICG injection",[37],[56],{"facility":57,"status":58,"city":59,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hospital Universitari Dr. Josep Trueta de Girona","RECRUITING","Girona","17001","Spain","ES",{"type":64,"coordinates":65},"Point",[66,67],2.82493,41.98311,{"lat":67,"lon":66},[70],{"name":71,"role":72,"phone":73,"phoneExt":25,"email":74},"Laia Falgueras Verdaguer MD","CONTACT","972 940 200","cirurgia.girona.ics@gencat.cat",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Laia Falgueras Verdaguer","General and Gastrointestinal Surgeon","100631543",false,"NCT07502053","Evaluation of the Perfusion of the Pancreatic Remnant With Indocyanine Green and Its Impact on the Reduction of Pancreatic Fistula After Pancreaticoduodenectomy","Evaluation of the Perfusion of the Pancreatic Remnant With Indocyanine Green and Its Impact on the Reduction of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Pilot Study","INDOPANC","Inclusion Criteria:\n\n* Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.\n* Age over 18 years.\n* Informed consent (IC) signed by the patient and the investigator\n\nExclusion Criteria:\n\n* Patients in whom it was not possible to perform a pancreaticojejunal anastomosis using the Blumgart technique.\n* Patients in whom an additional procedure was required during surgery, such as the resection of other organs.\n* Patients in whom resection was ruled out during surgery.\n* Allergy to iodine or shellfish.\n* Patients with psychiatric illnesses, addictions, or any disorder that prevents understanding of the informed consent (IC).","ALL","18 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"NA","Postoperative pancreatic fistula (POPF) is the most common complication following cephalic duodenopancreatectomy (DPC) and is a key determinant of severe postoperative morbidity and mortality. Despite numerous trials aimed at reducing POPF incidence, it remains high, ranging between 3% and 45%. The exact pathophysiology of pancreatic fistulas is not fully understood, but studies suggest that they may be related to pancreatic hypoperfusion after surgery, leading to ischemia, inflammation, pancreatitis, and failure of pancreatic anastomosis. Few studies focus on improving anastomotic failure through pancreatic perfusion, though ensuring adequate blood supply to the pancreas has shown promise in reducing failure rates.\n\nIndocyanine Green (ICG) has been widely used in various surgical fields to assess organ perfusion, including gastrointestinal, plastic, neuro, hepatic, and vascular surgeries, but it is underutilized in pancreatic surgery. ICG has shown potential to improve surgical outcomes, reduce perioperative morbidity, and decrease hospitalization costs. In the context of DPC, ICG could help assess pancreatic perfusion and identify areas of hypoperfusion, guiding the surgeon to extend resections to well-perfused areas. In summary, using ICG could potentially decrease the incidence of pancreatic fistulas, improve patient outcomes, reduce hospital stays, and lower the overall cost of patient care.",[96],"Postoperative Pancreatic Fistula Post-pancreatoduodenectomy","2026-03-24",{"date":99,"type":100},"2026-03-30","ACTUAL",{"date":102,"type":100},"2024-06-15",{"date":104,"type":90},"2027-06-15",{"name":5,"class":6},1]