Using indocyanine green to check blood flow in the pancreatic remnant during pancreaticoduodenectomy
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
Run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · NCT07502053 · Data updated 2026-11-12
This trial will try using indocyanine green during pancreaticoduodenectomy to visualize blood flow and see if that lowers postoperative pancreatic fistula in adults having the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona, Girona) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | June 15, 2026 |
| Study ends | June 15, 2027 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07502053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 planned for a cephalic pancreaticoduodenectomy with a planned Blumgart pancreaticojejunal anastomosis who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with iodine or shellfish allergy, those in whom the Blumgart anastomosis cannot be performed, those requiring additional organ resections, or cases where resection is aborted are not eligible and would not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergo cephalic pancreaticoduodenectomy and are compared between intraoperative indocyanine green (ICG) fluorescence imaging versus standard care without ICG to visualize perfusion of the pancreatic remnant. Surgeons use the fluorescence information to judge tissue perfusion before creating a Blumgart pancreaticojejunal anastomosis, and patients are followed for development of postoperative pancreatic fistula (POPF) and other complications. Key inclusion criteria are adults (>18) scheduled for the procedure who can provide informed consent, and key exclusions include inability to perform the Blumgart anastomosis, additional required resections, resection aborted intraoperatively, or allergy to iodine/shellfish. The trial is conducted at Hospital Universitari Dr. Josep Trueta de Girona with outcomes compared between the ICG and no-ICG groups.
Why it matters
Potential benefit: If successful, using ICG to guide the anastomosis could reduce the rate of postoperative pancreatic fistula and related complications.
How similar studies have gone: ICG fluorescence imaging is widely used to check perfusion in other surgical fields and small pancreatic surgery reports suggest promise, but high-quality evidence specifically reducing POPF remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, Spain Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.