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Clinical Trial NCT07502053 (INDOPANC) for Postoperative Pancreatic Fistula Post-pancreatoduodenectomy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Evaluation of the Perfusion of the Pancreatic Remnant With Indocyanine Green and Its Impact on the Reduction of Pancreatic Fistula After Pancreaticoduodenectomy (INDOPANC) 40

Recruiting
Clinical Trial NCT07502053 (INDOPANC) is an interventional study for Postoperative Pancreatic Fistula Post-pancreatoduodenectomy that is recruiting. It started on June 15, 2024 with plans to enroll 40 participants. Led by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, it is expected to complete by June 15, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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 pa...Show More
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

Conditions
Postoperative Pancreatic Fistula Post-pancreatoduodenectomy
Other Study IDs
  • INDOPANC
  • 2024.069
NCT ID Number
NCT07502053
Start Date (Actual)
2024-06-15
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-06-15
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIndocyanine 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...Show More
Indocyanine Green
ICG injection
ExperimentalNo 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.
No Indocyanine Green
No ICG injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
  • Age over 18 years.
  • Informed consent (IC) signed by the patient and the investigator

  • 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).
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta logoInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study Responsible Party
Laia Falgueras Verdaguer, Principal Investigator, General and Gastrointestinal Surgeon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
No contact data.
1 Study Locations in 1 Countries

Girona

Hospital Universitari Dr. Josep Trueta de Girona, Girona, Girona, 17001, Spain
Laia Falgueras Verdaguer MD, Contact, 972 940 200, [email protected]
Recruiting