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

NCT07502053 | Recruiting

• 1 other identifier: 2024.069
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pancreatic Fistula Post-pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy

  Surgery day

• Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green

  From day of surgery to hospital discharge (up to 30 days)

• 30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green

  Within 30 days after surgery

Study Arms (2)

Indocyanine Green

EXPERIMENTAL

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

No Indocyanine Green

EXPERIMENTAL

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

Interventions

No Indocyanine Green PROCEDURE

No ICG injection

No Indocyanine Green

Indocyanine Green PROCEDURE

ICG injection

Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
• Age over 18 years.
• Informed consent (IC) signed by the patient and the investigator

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Girona, 17001, Spain

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General and Gastrointestinal Surgeon

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: March 30, 2026
• Study Start: June 15, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

ES (1)