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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

About this trial

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 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.

Eligibility criteria

Qualifiers

Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.

Age over 18 years.

Informed consent (IC) signed by the patient and the investigator

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • No Indocyanine Green
  • Indocyanine Green

Treatment groups

40 Participants
are divided into 2 treatment groups