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NCT Number: NCT06198400

Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic

Prague, Czech Republic, 16000, Czechia

Location status: Recruiting

Location contact

Michael Rousek, MD

CONTACT

[email protected]

+420 973 202 903

Štěpán-Ota Schütz, MD

CONTACT

[email protected]

+420 7332 24 640

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Rousek

CONTACT

[email protected]

+420 973 202 903

Štěpán-Ota Schutz

CONTACT

[email protected]

+420 7332 24 640

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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