Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks
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.
Arms & interventions
- OtherNon-Interventional Study
Non-interventional study
Outcome measures
Primary
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 surgery
Perfusion status
Measured by Indocyanine green (ICG) metrics.
Time frame: During surgical intervention (hours)
Secondary
Leak grade via ISGPS classification
Time frame: Up to 30 days after surgery
Leak grade by ICG metrics
Time frame: Up to 30 days after surgery
Best practice usage of ICG for pancreatic surgery
Time frame: Assessed at surgery number 15, approximate 6 months
Eligibility criteria
Study locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239
References
- Salgado-Garza G, Willy A, Rocha FG, Mayo SC, Sheppard BC, Worth PJ. The VIPR-1 trial (Visualizing Ischemia in the Pancreatic Remnant): Assessing the role of intraoperative indocyanine green perfusion in predicting postoperative pancreatic leaks and fistulas: Protocol for a phase II clinical trial. PLoS One. 2025 Jun 24;20(6):e0311025. doi: 10.1371/journal.pone.0311025. eCollection 2025.(PubMed)