Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

August 19, 2024 updated by: Štěpán-Ota Schütz, Charles University, Czech Republic

Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy

Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatoduodenectomy is associated with nearly 25% incidence of postoperative complications. One of the most severe complications is a postoperative pancreatic fistula. The exact cause of postoperative fistula development is still unknown, but it appears to be multifactorial. Proper perfusion of pancreatic remnant is essential for the healing of pancreaticojejunostomy. To date, there is no method to reliably evaluate the vascular supply of the remnant. One of the methods for assessment of organ perfusion is the indocyanine green fluorescence. This study aims to determine if indocyanine green fluorescence is a reliable method to measure the perfusion of the post-resection pancreatic remnant. Secondary outcome is to determine, if perioperative evaluation of the vascular supply of the postresection remnant may predict the increased risk of the postoperative pancreatic fistula development.

This study is designed as a prospective experimental study. All consecutive patients undergoing open pancreaticoduodenectomy at our department in the 1.5.2024-31.12.2026 period will be enrolled. Exclusion criteria are allergy to indocyanine green and refusal by the patient.The adequacy of the vascular supply of the post-resection pancreatic remnant will be perioperatively evaluated using fluorescence detector. Patients will be divided into two groups. Those with hazardous and non-hazardous vascular supply. The incidence of pancreatic fistula in both groups is to be compared. Postoperative data including morbidity, mortality, hospital stay, intensive care unit stay and postoperative fistula development will be collected.

If a perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green is proven to be a suitable method to estimate the increased risk of the pancreatic fistula, the list of the existing known risk factors could be expanded. In the most high-risk patients the modification of the surgical procedure could be considered.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • Czech Republic
      • Prag, Czech Republic, Czechia, 16000
        • Recruiting
        • Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period

Exclusion Criteria:

  • Allergy to indocyanine green
  • Refusal by the patient
  • Mini-invasive procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients undergoing the pancreaticoduodenectomy
All consecutive patients undergoing the pancreaticoduodenectomy at our institution in the 1.5.2024-31.12.2026 period will be enrolled in this study.
Diagnostic test: Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye
The adequacy of the vascular supply of the post resection pancreatic remnant after pancreatic neck division will be evaluated using ICG detector. Indocyanine green fluorescence product -Verdye™ will be intravenously applied. The application of the substance will be performed according to the current consensus statement and recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the blood flow in pancreatic remnant with use of ICG
Time Frame: Intraoperatively: 5-10 minutes
Primary outcome of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of ICG fluorescence.
Intraoperatively: 5-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ICG perfusion and development of pancreatic fistula
Time Frame: From admission to discharge, up to 2 weeks
Secondary outcome of this study is to find possible correlation between ICG finding and higher rate of postoperative pancreatic fistula development which could lead to establishment of new predictive risk factor.
From admission to discharge, up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Study Director: Radek Pohnán, Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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