An interventional study of No Indocyanine Green and Indocyanine Green in Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Not applicable, Interventional, and Prevention
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.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once the pancreas has been resected and the specimen is outside, before performing the pancreatic-jejunal anastomosis, ICG will be injected. A dose of 0.1 mg/kg of ICG will be used, which is within a safe range. After injecting the ICG, the surgeon will wait for up to 90 seconds to assess if there is hypoperfusion of the pancreatic margin. If hypoperfusion is observed, an extension of the resection will be performed towards the left (normally 1.5 - 2 cm) from the neck of the pancreas, until a well-perfused pancreatic area is reached. Once the resection margin has been extended, the pancreatic-jejunal anastomosis will be performed according to the standard technique.
Procedure: Indocyanine Green
Once the pancreas has been resected and the specimen is outside, we will perform the pancreatic-jejunal anastomosis according to the Blumgart technique and complete the surgery.
Procedure: No Indocyanine Green
No ICG injection
ICG injection
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
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
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)
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
Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 24 months after the start.
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta