Clinical trial NCT06084013: Use of Indocyanine Green in Pancreas Surgery
Official title: Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis

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.

Eligibility 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
* 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

Primary outcomes:
measure: Incidence of biochemical leak or fistula after pancreatectomy.
timeFrame: Up to 30 days after surgery
measure: Perfusion status
timeFrame: During surgical intervention (hours)
Secondary outcomes:
measure: Leak grade via ISGPS classification
timeFrame: Up to 30 days after surgery
measure: Leak grade by ICG metrics
timeFrame: Up to 30 days after surgery
measure: Best practice usage of ICG for pancreatic surgery
timeFrame: Assessed at surgery number 15, approximate 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Patrick J Worth
role: PRINCIPAL_INVESTIGATOR
References: