Use of Indocyanine Green in Pancreas Surgery

Launched by OHSU KNIGHT CANCER INSTITUTE · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special dye called indocyanine green to help doctors predict whether patients will experience leaks in their pancreas after surgery. This is particularly important for individuals undergoing specific types of pancreas surgeries, such as pancreaticoduodenectomy or distal pancreatectomy, especially for pancreatic cancer. The goal is to improve patient outcomes by identifying potential problems early.

To participate, patients must be at least 18 years old, scheduled for one of the mentioned surgeries, and able to understand the trial's purpose. They also need to agree to have a drain placed after surgery to help monitor their recovery. However, individuals with certain health issues, like a history of allergic reactions to similar dyes or serious liver problems, will not be eligible. Participants can expect to receive close monitoring during their recovery, helping doctors take better care of them after surgery.

Gender

ALL

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