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NCT Number: NCT07502053

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17001, Spain

Location status: Recruiting

Location contact

Laia Falgueras Verdaguer MD

CONTACT

[email protected]

972 940 200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No Indocyanine Green

Procedure

No ICG injection

Indocyanine Green

Procedure

ICG injection

Primary outcomes

  1. Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green

    Time frame: Within 30 days after surgery

    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.

Secondary outcomes

  1. Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy

    Time frame: Surgery day

    Extent of pancreatic resection during pancreaticoduodenectomy, assessed intraoperatively. This includes whether an extended resection beyond the standard procedure was performed (yes/no).

  2. Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green

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

    Length of hospital stay, measured as the number of days from surgery to hospital discharge following pancreaticoduodenectomy.

  3. 30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green

    Time frame: Within 30 days after surgery

    Mortality within 30 days after pancreaticoduodenectomy, defined as death from any cause occurring within 30 days following surgery.

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study 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

Acronym: INDOPANC

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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