NCT06084013Recruiting
Use Of Indocyanine Green In Pancreas Surgery
OHSU Knight Cancer Institute
Start Date
5/17/2024
Completion Date
2/28/2028
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 green intravenously (IV) during surgery, undergo imaging and have their medical records reviewed on study.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
OTHER
Non-Interventional Study
Conditions
Pancreatic Carcinoma
Locations
OHSU Knight Cancer Institute
Portland, Oregon 97239
United States