Fluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
ID
Bron
Verkorte titel
Aandoening
ureteral damage, Near infrared fluorescence imaging, Methylene blue
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Intra-operative identification rate, defined as the number of ureters that were identified with the fluorescent signal of methylene blue during operation.
Achtergrond van het onderzoek
Iatrogenous ureteral injury is a rare, but serious complication of lower abdominal surgery. Ureteral damage is often missed and it can lead to severe morbidity such as genitourinary fistula formation or major renal complications. Near-infrared (NIR) fluorescence imaging is a promising technique that offers intraoperative, real-time, visual information during surgery. Methylene blue (MB) becomes a moderate-strength fluorophore emitting at ¡Ö 700 nm when diluted to levels that are almost undetectable to the human eye. Since MB is cleared renally, we hypothesized that low-dose MB can be used as a NIR fluorescent tracer for intraoperative identification of the ureters.
Doel van het onderzoek
Fluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery.
Onderzoeksproduct en/of interventie
Patients will receive standard of care. During surgery, methylene blue will be injected intravenously to identify the ureters using NIR fluorenscence.
Algemeen / deelnemers
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Wetenschappers
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients planned to undergo surgery in the lower abdomen;
2. Minimum age of 18.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
Opzet
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| Register | ID |
|---|---|
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