Clinical trial NCT06198400: Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.
Official title: Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Pancreatic surgery
ICG
Minimal invasive surgery,
Pancreatic cancer
Pancreatic perfusion
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the blood flow in pancreatic remnant with use of ICG
timeFrame: Intraoperatively: 5-10 minutes
Secondary outcomes:
measure: Correlation between ICG perfusion and development of pancreatic fistula
timeFrame: From admission to discharge, up to 2 weeks
Other outcomes:
Locations:
city: Prag
country: Czechia
facility: Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic
state: Czech Republic
Study officials:
affiliation: Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic
name: Radek Pohnán
role: STUDY_DIRECTOR
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