RecruitingNot ApplicableNCT07502053

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


Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Enrollment

40 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
  • Age over 18 years.
  • Informed consent (IC) signed by the patient and the investigator

Exclusion Criteria5

  • 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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Interventions

PROCEDURENo Indocyanine Green

No ICG injection

PROCEDUREIndocyanine Green

ICG injection


Locations(1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Girona, Spain

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NCT07502053