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Observational Study of Indocyanine Green in Pancreas Surgery

This study is looking at how a special dye called indocyanine green (ICG) can help doctors predict problems after pancreas surgery. Specifically, it aims to see if changes in ICG measurements during surgery are linked to pancreatic leaks or fistulas (abnormal connections) that can happen up to 30 days after the operation. You might be able to join if you are at least 18 years old and are scheduled for open pancreaticoduodenectomy or distal pancreatectomy (types of pancreas surgery) for any reason. The study is considered successful if it can show a connection between ICG measurements and these leaks. The current status of this study is unclear, and it plans to include about 55 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to include about 55 participants.
What's involved
You would receive indocyanine green intravenously (through a vein) during surgery, undergo imaging, and have your medical records reviewed.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure the incidence of biochemical leak or fistula for up to 30 days after surgery.

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NCT06084013

Use Of Indocyanine Green In Pancreas Surgery

Recruiting
Not specifiedAges 18+Observational
OHSU Knight Cancer Institute
~55 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of biochemical leak or fistula after pancreatectomy.
Measured over Up to 30 days after surgery
+1 more outcome measured

Conditions

Pancreatic Carcinoma

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Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Patrick J Worth · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Gustavo Salgado-Garza, MD
[email protected]
503-494-6900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
Participant ≥ 18 years of age
Ability to understand nature and individual consequences of clinical trial
Written informed consent from participant or legally authorized representative
For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
Participant needs to have an operative drain (any closed suction drain) after the procedure
Participants that do not require arterial reconstruction
Participants that require minor portal venous recounstructions including patch venoplasty

Exclusion

Patients with previous history of adverse reaction to contrast dye, ICG or components of the dye
Prior pancreatectomy
Known diagnosis of hepatic insufficiency, hepatitis, liver fibrosis or cirrhosis, or chronic pancreatitis
Because this study focuses on hypoperfusion, patients will be excluded if in postoperative day 3-5 had any of the following: persistent SBP \<90 mmHg unresponsive to 1L crystalloid, unexpected ICU transfer, blood transfusion of \>2 units intraoperatively or 1 postoperatively, vasopressor treatment or ACLS protocol initiation
Organ failure, anuria or NSQIP-identified complication will be reviewed by PI and attending surgeon and excluded
Patients that require arterial reconstruction as part of their procedures

What this trial measures

  • Incidence of biochemical leak or fistula after pancreatectomy.Up to 30 days after surgery

    Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria

  • Perfusion statusDuring surgical intervention (hours)

    Measured by Indocyanine green (ICG) metrics.