Postoperative Pancreatic Fistula Post-pancreatoduodenectomyINDOPANCNCT07502053
Evaluation of the Perfusion of the Pancreatic Remnant With Indocyanine Green and Its Impact on the Reduction of Pancreatic Fistula After Pancreaticoduodenectomy
A study testing No Indocyanine Green and Indocyanine Green in people with Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pancreatic Fistula Post-pancreatoduodenectomy
- What is being tested?
- No Indocyanine Green and Indocyanine Green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2024to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
- Age over 18 years.
- Informed consent (IC) signed by the patient and the investigator
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Girona, 17001
Laia Falgueras Verdaguer MD, 972 940 200, cirurgia.girona.ics@gencat.cat
About this study
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
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.
- Being tested
- No Indocyanine Green, Indocyanine Green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Indocyanine GreenProcedure or surgery
No ICG injection
Indocyanine GreenProcedure or surgery
ICG injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: No Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Jun 2024
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pancreatic Fistula Post-pancreatoduodenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laia Falgueras Verdaguer, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502053
- Sponsor's protocol ID
- 2024.069
- Acronym
- INDOPANC
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07502053
- Acronym / sponsor ID
- INDOPANC / 2024.069
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Procedure: Indocyanine GreenOnce 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. |
| No Indocyanine Green | Experimental | Procedure: No Indocyanine GreenOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients for whom a Cephalic Pancreaticoduodenectomy is indicated.
- Age over 18 years.
- Informed consent (IC) signed by the patient and the investigator
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Indocyanine GreenNo ICG injection | Procedure or surgery | No Indocyanine Green |
| Indocyanine GreenICG injection | Procedure or surgery | Indocyanine Green |
Primary outcome
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.
3 secondary outcomes
Effect of indocyanine green on the extent of pancreatic resection during pancreaticoduodenectomy
Time frame: Surgery day
Length of hospital stay following pancreaticoduodenectomy in patients receiving indocyanine green
Time frame: From day of surgery to hospital discharge (up to 30 days)
30-day mortality following pancreaticoduodenectomy in patients receiving indocyanine green
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Indocyanine Green and Indocyanine Green in people with Postoperative Pancreatic Fistula Post-pancreatoduodenectomy, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pancreatic fistula following pancreaticoduodenectomy in patients receiving indocyanine green (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.