Status:
RECRUITING
Use Of Indocyanine Green In Pancreas Surgery
Lead Sponsor:
OHSU Knight Cancer Institute
Conditions:
Pancreatic Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
Detailed Description
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 gr...
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
Key Trial Info
Start Date :
May 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06084013
Start Date
May 17 2024
End Date
February 28 2026
Last Update
July 25 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239