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