Use Of Indocyanine Green In Pancreas Surgery

NCT06084013 | Recruiting

• 2 other identifiers: STUDY00025055NCI-2023-07105
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Leak grade via ISGPS classification

  Up to 30 days after surgery

• Leak grade by ICG metrics

  Up to 30 days after surgery

• Best practice usage of ICG for pancreatic surgery

  Assessed at surgery number 15, approximate 6 months

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• Salgado-Garza G, Willy A, Rocha FG, Mayo SC, Sheppard BC, Worth PJ. The VIPR-1 trial (Visualizing Ischemia in the Pancreatic Remnant): Assessing the role of intraoperative indocyanine green perfusion in predicting postoperative pancreatic leaks and fistulas: Protocol for a phase II clinical trial. PLoS One. 2025 Jun 24;20(6):e0311025. doi: 10.1371/journal.pone.0311025. eCollection 2025.

  PMID: 40554527 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Patrick J Worth

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Salgado-Garza, MD

CONTACT

503-494-6900; salgadog@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 16, 2023
• Study Start: May 17, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)