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

Condition(s) studied

Investigational drug(s) / intervention(s)

No Indocyanine Green: No ICG injection

Indocyanine Green: ICG injection

Study summary

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

Primary outcome measure(s)

• Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green — Within 30 days after surgery
  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.

Trial sites (1)

More Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials in Spain