Postoperative Pancreatic Fistula Post-pancreatoduodenectomy
Conditions
Brief 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.
Interventions
PROCEDURENo Indocyanine Green
No ICG injection
PROCEDUREIndocyanine Green
ICG injection
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green | Within 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy | Surgery day | Extent of pancreatic resection during pancreaticoduodenectomy, assessed intraoperatively. This includes whether an extended resection beyond the standard procedure was performed (yes/no). |
| Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green | From day of surgery to hospital discharge (up to 30 days) | Length of hospital stay, measured as the number of days from surgery to hospital discharge following pancreaticoduodenectomy. |
| 30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green | Within 30 days after surgery | Mortality within 30 days after pancreaticoduodenectomy, defined as death from any cause occurring within 30 days following surgery. |
Countries
Spain
Outcome results
None listed