Use Of Indocyanine Green In Pancreas Surgery
Study Details
Study Description
Brief Summary
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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), undergo imaging and have their medical records reviewed on study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational Patients receive indocyanine green IV, undergo imaging and have their medical records reviewed on study. |
Other: Non-Interventional Study
Non-interventional study
|
Outcome Measures
Primary Outcome Measures
- Incidence of biochemical leak or fistula after pancreatectomy. [Up to 30 days after surgery]
Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria
- Perfusion status [During surgical intervention (hours)]
Measured by Indocyanine green (ICG) metrics.
Secondary Outcome Measures
- Leak grade via ISGPS classification [Up to 30 days after surgery]
Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula
- Leak grade by ICG metrics [Up to 30 days after surgery]
ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.
- Best practice usage of ICG for pancreatic surgery [Assessed at surgery number 15, approximate 6 months]
Measures through verbal survey to surgeons or OR members
Eligibility Criteria
Criteria
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
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For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
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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 contraste dye, ICG or components of the dye
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Prior pancreatectomy
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Known diagnosis of hepatic insufficiency, hepatitis, liver fibrosis or cirrhosis, or chronic pancreatitis
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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
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Patients that require arterial reconstruction as part of their procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
Investigators
- Principal Investigator: Patrick J Worth, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00025055
- NCI-2023-07105
- STUDY00025055