Use Of Indocyanine Green In Pancreas Surgery

Pancreatic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084013
• Other study ID #: STUDY00025055
• Secondary ID: NCI-2023-07105ST
• Status: Recruiting
• Start date: June 10, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: OHSU Knight Cancer Institute
• Contact: Gustavo Salgado-Garza, MD
• Phone: 503-494-6900
• Email: salgadog[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Up to 30 days after surgery
Primary	Perfusion status	Measured by Indocyanine green (ICG) metrics.	During surgical intervention (hours)
Secondary	Leak grade via ISGPS classification	Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula	Up to 30 days after surgery
Secondary	Leak grade by ICG metrics	ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.	Up to 30 days after surgery
Secondary	Best practice usage of ICG for pancreatic surgery	Measures through verbal survey to surgeons or OR members	Assessed at surgery number 15, approximate 6 months