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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pancreatic Fistula Post-pancreatoduodenectomy
• Intervention / Treatment: Procedure: Indocyanine Green; Procedure: No Indocyanine Green

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Girona
    • Girona, Girona, Spain, 17001
      • Recruiting
      • Hospital Universitari Dr. Josep Trueta de Girona
      • Contact: Laia Falgueras Verdaguer MD; Phone Number: 972 940 200; Email: cirurgia.girona.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indocyanine Green; 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; ICG injection
Experimental: No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 2024.069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No