Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.
ConditionPancreatic Fistula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period
Disqualifiers
Allergy to indocyanine green
Refusal by the patient
Mini-invasive procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye
Diagnostic testThe 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: All patients undergoing the pancreaticoduodenectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the blood flow in pancreatic remnant with use of ICG
Primary outcome of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of ICG fluorescence.
Time frame
Intraoperatively: 5-10 minutesSecondary outcomes
1
Correlation between ICG perfusion and development of pancreatic fistula
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.
Time frame
From admission to discharge, up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov