Use of Indocyanine Green in Pancreas Surgery

Recruiting

• Conditions: Pancreatic Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06084013
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-16
• Study Start: 2024-05-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Perfusion status	During surgical intervention (hours)	Measured by Indocyanine green (ICG) metrics.
Incidence of biochemical leak or fistula after pancreatectomy.	Up to 30 days after surgery	Measurement of drain fluid amylase in post operative period. Defined by definitions of the International Study Group on Pancreatic Surgery (ISGPS) criteria

Secondary Outcome Measures

Name	Time	Method
Leak grade via ISGPS classification	Up to 30 days after surgery	Can be either bile leak, Grade B postoperative pancreatic fistula or grade C postoperative pancreatic fistula
Leak grade by ICG metrics	Up to 30 days after surgery	ISGPS classification of leak or fistula and the perfusion metrics measures by ICG.
Best practice usage of ICG for pancreatic surgery	Assessed at surgery number 15, approximate 6 months	Measures through verbal survey to surgeons or OR members

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States