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NCT Number: NCT06084013

Use Of Indocyanine Green In Pancreas Surgery

This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Patrick J. Worth

CONTACT

[email protected]

503-346-0243

Patrick J. Worth

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To determine if altered measurement results of ICG after pancreatectomy is associated with leak rates.

OUTLINE: This is an observational study.

Patients receive indocyanine green intravenously (IV) during surgery, undergo imaging and have their medical records reviewed on study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Incidence of biochemical leak or fistula after pancreatectomy.

    Time frame: 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

  2. Perfusion status

    Time frame: During surgical intervention (hours)

    Measured by Indocyanine green (ICG) metrics.

Secondary outcomes

  1. Leak grade via ISGPS classification

    Time frame: Up to 30 days after surgery

    Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula

  2. Leak grade by ICG metrics

    Time frame: Up to 30 days after surgery

    ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.

  3. Best practice usage of ICG for pancreatic surgery

    Time frame: Assessed at surgery number 15, approximate 6 months

    Measures through verbal survey to surgeons or OR members

Study contacts

Contact information is provided by the study sponsor or research team.

Gustavo Salgado-Garza, MD

CONTACT

[email protected]

503-494-6900

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Registry information

Official study title

Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 16, 2023
Registry last updated
Jul 9, 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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