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Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06198400
Enrollment
60
Registered
2024-01-10
Start date
2024-05-01
Completion date
2027-07-01
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

Pancreatic surgery, ICG, Minimal invasive surgery,, Pancreatic cancer, Pancreatic perfusion

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTPerioperative 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

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the blood flow in pancreatic remnant with use of ICGIntraoperatively: 5-10 minutesPrimary outcome of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of ICG fluorescence.

Secondary

MeasureTime frameDescription
Correlation between ICG perfusion and development of pancreatic fistulaFrom admission to discharge, up to 2 weeksSecondary 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.

Countries

Czechia

Contacts

Primary ContactŠtěpán-Ota Schutz
schutz.stepan-ota@uvn.cz+420 7332 24 640
Backup ContactMichael Rousek
Michael.Rousek@uvn.cz+420 973 202 903

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026