Use Of Indocyanine Green In Pancreas Surgery

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

Detailed Description
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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.

Official Title
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Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Other: Non-Interventional Study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biochemical leak or fistula after pancreatectomy. | Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria | Up to 30 days after surgery | 
| Perfusion status | Measured by Indocyanine green (ICG) metrics. | During surgical intervention (hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak grade via ISGPS classification | Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula | Up to 30 days after surgery | 
| Leak grade by ICG metrics | ISGPS classification of leak or fistula and the perfusion metrics measures by ICG. | Up to 30 days after surgery | 
| Best practice usage of ICG for pancreatic surgery | Measures through verbal survey to surgeons or OR members | Assessed at surgery number 15, approximate 6 months |