Recruiting

Indocyanine Green

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06084013

Conditions

Pancreatic Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Conditions

Pancreatic Carcinoma

Study ID

NCT06084013

Start date

Feb 29, 2024

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Incidence of biochemical leak or fistula after pancreatectomy. [ Time Frame: Up to 30 days after surgery ]
  • Perfusion status [ Time Frame: During surgical intervention (hours) ]

Central Contacts and Locations

Central contacts

Gustavo Salgado-Garza, MD

503-494-6900salgadog@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Patrick J. Worth

503-346-0243worth@ohsu.edu

Principal Investigator:

Patrick J. Worth

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-08-31.