RECRUITING

Use of Indocyanine Green in Pancreas Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-17

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06084013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Gustavo Salgado-Garza, MD

CONTACT

503-494-6900

salgadog@ohsu.edu

Principal Investigator

Patrick J Worth

PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

Patrick J Worth, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-17

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-05-17

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Carcinoma