Use Of Indocyanine Green In Pancreas Surgery
ConditionPancreatic Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute
About this trial
This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 30 days after surgery2
Perfusion status
Measured by Indocyanine green (ICG) metrics.
Time frame
During surgical intervention (hours)Secondary outcomes
1
Leak grade via ISGPS classification
Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula
Time frame
Up to 30 days after surgery2
Leak grade by ICG metrics
ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.
Time frame
Up to 30 days after surgery3
Best practice usage of ICG for pancreatic surgery
Measures through verbal survey to surgeons or OR members
Time frame
Assessed at surgery number 15, approximate 6 monthsSponsors and contacts
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Source ClinicalTrials.gov