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Evaluation of the Perfusion of the Pancreatic Remnant With Indocyanine Green and Its Impact on the Reduction of Pancreatic Fistula After Pancreaticoduodenectomy

RecruitingNAAges 18 Years - anyAllInstitut d'Investigació Biomèdica de Girona Dr. J…
NCT07502053 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Indocyanine Green (ICG) has been widely used in various surgical fields to assess organ perfusion, including gastrointestinal, plastic, neuro, hepatic, and vascular surgerie

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients for whom a Cephalic Pancreaticoduodenectomy is indicated. * Age over 18 years. * Informed consent (IC) signed by the patient and the investigator Exclusion Criteria: * Patients in whom it was not possible to perform a pancreaticojejunal anastomosis using the Blumgart technique. * Patients in whom an additional procedure was required during surgery, such as the resection of other organs. * Patients in whom resection was ruled out during surgery. * Allergy to iodine or shellfish. * Patients with psychiatric illnesses, addictions, or any disorder that prevents understanding of the informed consent (IC).
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What it tests

  • No Indocyanine Green
  • Indocyanine Green
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Where

1 site
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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