Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07502053

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

Led by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Updated on 2026-03-30

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
  • Age over 18 years.
  • Informed consent signed by the patient and investigator.
Not Eligible

You will not qualify if you...

  • Patients in whom it was not possible to perform a pancreaticojejunal anastomosis using the Blumgart technique.
  • Patients requiring additional procedures during surgery, such as 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 preventing understanding of informed consent.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Girona, Spain, 17001

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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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 | DecenTrialz