Use Of Indocyanine Green In Pancreas Surgery

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Gustavo Salgado-Garza, MD; Phone Number: 503-494-6900; Email: salgadog@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
      • Contact: Patrick J. Worth; Phone Number: 503-346-0243; Email: worth@ohsu.edu
      • Principal Investigator: Patrick J. Worth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Perfusion status	Measured by Indocyanine green (ICG) metrics.	During surgical intervention (hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Leak grade by ICG metrics	ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.	Up to 30 days after surgery
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

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Investigators: Principal Investigator: Patrick J Worth, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: STUDY00025055 (Other Identifier: OHSU Knight Cancer Institute); NCI-2023-07105 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No