Using indocyanine green to check blood flow in the pancreatic remnant during pancreaticoduodenectomy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona, Girona) |
| Trial ID | NCT07502053 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 planned for a cephalic pancreaticoduodenectomy with a planned Blumgart pancreaticojejunal anastomosis who can give informed consent are ideal candidates.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Girona, Girona
- Hospital Universitari Dr. Josep Trueta de Girona — Girona, Girona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.