Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

Charles University, Czech Republic

Status: Enrolling

Conditions: Pancreatic Fistula

Treatments: Diagnostic Test: Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye

Study type: Interventional

Funder types: Other

Identifiers

NCT06198400

MO1012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

All patients undergoing the pancreaticoduodenectomy

Experimental group

Description:

All consecutive patients undergoing the pancreaticoduodenectomy at our institution in the 1.5.2024-31.12.2026 period will be enrolled in this study.

Treatment:

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