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Trial Title:
Use of Indocyanine Green in Pancreas Surgery
NCT ID:
NCT06084013
Condition:
Pancreatic Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any
diagnosis
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick J. Worth
Phone:
503-346-0243
Email:
worth@ohsu.edu
Contact backup:
Last name:
Patrick J. Worth
Start date:
May 17, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084013
