Using indocyanine green to predict leaks after pancreas surgery

Assessing the Role of Intraoperative Indocyanine Green Perfusion of the Transected Pancreas in Predicting Postoperative Pancreatic Leaks

This study is testing if a special dye given during pancreas surgery can help doctors predict if patients will have leaks after the operation.

Quick facts

• Study type: Observational
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OHSU Knight Cancer Institute (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06084013 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of indocyanine green (ICG) in predicting postoperative pancreatic leaks in patients undergoing pancreas surgery. Participants will receive ICG intravenously during their procedure, followed by imaging and a review of their medical records to assess leak rates. The primary objective is to determine if changes in ICG measurements after surgery correlate with the occurrence of leaks. This study aims to improve surgical outcomes for patients undergoing pancreaticoduodenectomy or distal pancreatectomy.

Who should consider this trial

Good fit: Ideal candidates include adults scheduled for open pancreaticoduodenectomy or distal pancreatectomy who can provide informed consent.

Not a fit: Patients with a history of adverse reactions to contrast dye or those with significant liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better prediction and management of postoperative complications in pancreas surgery.

How similar studies have performed: While the use of indocyanine green in surgical settings is gaining interest, this specific application in pancreas surgery is relatively novel and has not been extensively tested.

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

Where this trial is running

Portland, Oregon

• OHSU Knight Cancer Institute — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Patrick J Worth — OHSU Knight Cancer Institute
• Study coordinator: Gustavo Salgado-Garza, MD

Conditions: Pancreatic Carcinoma