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Use Of Indocyanine Green In Pancreas Surgery
RECRUITINGSponsored by OHSU Knight Cancer Institute
Actively Recruiting
SponsorOHSU Knight Cancer Institute
Started2024-05-17
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06084013
Summary
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
Eligibility
Age: 18 Years+Healthy volunteers 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
Conditions2
CancerPancreatic Carcinoma
Locations1 site
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Actively Recruiting
SponsorOHSU Knight Cancer Institute
Started2024-05-17
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06084013