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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pancreatic Fistula Post-pancreatoduodenectomy

Interventions

Type	Name	Description
PROCEDURE	No Indocyanine Green	No ICG injection
PROCEDURE	Indocyanine Green	ICG injection

Timeline

• Start date: 2024-06-15
• Primary completion: 2026-06-15
• Completion: 2027-06-15
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Spain