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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.

Age over 18 years.

Informed consent (IC) signed by the patient and the investigator

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • No Indocyanine Green

    Procedure/Surgery

    No ICG injection

  • Indocyanine Green

    Procedure/Surgery

    ICG injection

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Indocyanine GreenExperimental treatment 1 intervention
Group B: No Indocyanine GreenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green

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.

Time frame
Within 30 days after surgery

Secondary outcomes

1

Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy

Extent of pancreatic resection during pancreaticoduodenectomy, assessed intraoperatively. This includes whether an extended resection beyond the standard procedure was performed (yes/no).

Time frame
Surgery day
2

Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green

Length of hospital stay, measured as the number of days from surgery to hospital discharge following pancreaticoduodenectomy.

Time frame
From day of surgery to hospital discharge (up to 30 days)
3

30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green

Mortality within 30 days after pancreaticoduodenectomy, defined as death from any cause occurring within 30 days following surgery.

Time frame
Within 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.