Use Of Indocyanine Green In Pancreas Surgery

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Pancreatic Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06084013

NCI-2023-07105 (Registry Identifier)

STUDY00025055 (Other Identifier)

Details and patient eligibility

About

This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Observational

Description:

Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study.

Treatment:

Other: Non-Interventional Study