Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors.
Prashanth Rawla, Tagore Sunkara, Vinaya Gaduputi
https://pubmed.ncbi.nlm.nih.gov/30834048Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06198400
Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy
Led by Charles University, Czech Republic · Updated on 2024-08-21
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the blood flow in the pancreatic remnant after pancreaticoduodenectomy using indocyanine green fluorescence. This is to see if this method can help estimate the risk of developing a postoperative pancreatic fistula, a serious complication that occurs in about 25% of these surgeries. The study is prospective and experimental, focusing on patients undergoing open pancreaticoduodenectomy from May 2024 to December 2026. During surgery, all patients will receive an intravenous application of indocyanine green fluorescence product, Verdye™, to assess the blood supply of the pancreatic remnant with a fluorescence detector. Patients will be categorized into groups based on whether their pancreatic remnant shows hazardous or non-hazardous vascular supply. The study will compare the incidence of pancreatic fistula and other postoperative outcomes between these groups. Participants will be monitored from admission until discharge, with data collected on complications, mortality, length of hospital and intensive care stays, and development of pancreatic fistula. The primary measurement is the evaluation of blood flow during the operation using indocyanine green fluorescence within 5 to 10 minutes. Secondary outcomes include correlating perfusion results with fistula development over approximately two weeks post-surgery. The overall goal is to improve prediction of fistula risk and potentially guide surgical decisions.
CONDITIONS
Brief Title
Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period
You will not qualify if you...
- Allergy to indocyanine green
- Refusal by the patient
- Mini-invasive procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Intraoperatively: 5-10 minutes
Participants undergo pancreaticoduodenectomy surgery during which the blood flow in the pancreatic remnant is evaluated using indocyanine green fluorescence. This perioperative assessment helps determine the adequacy of vascular supply to the pancreatic remnant.
1 surgical procedure visit
Post-operative Follow-up
Duration - Up to 2 weeks
Participants are monitored after surgery to observe clinical outcomes including the development of pancreatic fistula, morbidity, mortality, hospital stay, and intensive care unit stay.
Visits from admission to discharge
Trial Site Locations
Total: 1 location
1
Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic
Prague, Czech Republic, Czechia, 16000
Actively Recruiting
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Research Team
Š
Štěpán-Ota Schutz
M
Michael Rousek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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