Use Of Indocyanine Green In Pancreas Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-17

Study Completion Date

2026-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreatic Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No