Pancreatic Carcinoma
Conditions
Brief 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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
OHSU Knight Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTGustavo Salgado-Garza, MD
PRINCIPAL_INVESTIGATORPatrick J Worth
OHSU Knight Cancer Institute
Outcome results
None listed