Evaluating blood flow in pancreatic remnants after surgery using fluorescence
Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy
This study is testing if a special dye can help doctors see blood flow in the remaining part of the pancreas after surgery to predict the risk of complications like pancreatic fistulas in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague, Czech Republic) |
| Trial ID | NCT06198400 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the blood flow in the pancreatic remnant following pancreaticoduodenectomy by utilizing indocyanine green fluorescence. The research will involve consecutive patients undergoing this surgical procedure from May 2024 to December 2026. By evaluating the vascular supply of the pancreatic remnant, the study seeks to determine if this method can predict the risk of developing postoperative pancreatic fistulas. Patients will be categorized based on the adequacy of their vascular supply, and the incidence of complications will be compared between groups.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for open pancreaticoduodenectomy during the study period.
Not a fit: Patients with allergies to indocyanine green or those undergoing mini-invasive procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of pancreatic fistulas after surgery, improving patient outcomes.
How similar studies have performed: While the use of indocyanine green fluorescence for perfusion assessment is gaining traction, this specific application in pancreatic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Prague, Czech Republic
- Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic — Prague, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: Štěpán-Ota Schutz
- Email: schutz.stepan-ota@uvn.cz
- Phone: +420 7332 24 640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.