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Recruiting NCT07502053

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

No phase Interventional Postoperative Pancreatic Fistula Post-pancreatoduodenectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Indocyanine Green, Indocyanine Green.
Who it may be relevant to
Registry conditions: Postoperative Pancreatic Fistula Post-pancreatoduodenectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure No Indocyanine Green
    No ICG injection
  • Procedure Indocyanine Green
    ICG injection

Primary outcome measures

  • Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green [Time frame: Within 30 days after surgery]
Secondary outcome measures (3)
  • Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy [Time frame: Surgery day]
  • Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green [Time frame: From day of surgery to hospital discharge (up to 30 days)]
  • 30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green [Time frame: Within 30 days after surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Universitari Dr. Josep Trueta de Girona — Girona

Identifiers

NCT: NCT07502053 · 2024.069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗