Delayed fluorescence imaging is optimal for visualization of bile ducts compared to the surrounding liver.
ID
Bron
Verkorte titel
Aandoening
intraoperative clarification of bile duct anatomy using NIR fluorescence imaging
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Identification of bile ducts using laparoscopic NIR fluorescence imaging during laparoscopic cholecystectomy.
Achtergrond van het onderzoek
Bile duct identification during laparoscopic cholecystectomy can be challanging. Near-infrared fluroescence cholangiography is an innovative technique enabling real-time identification of bile duct anatomy after injection of the fluorophore indocyanine green (ICG).
However, distinction between liver and bile ducts
is of utmost important to make this technique widely applicable and usefull. No optimal dose of ICG and time of administration have ever been investigated. In the current study, we aim to optimize both factors.
Doel van het onderzoek
Delayed fluorescence imaging is optimal for visualization of bile ducts compared to the surrounding liver.
Onderzoeksopzet
The primary and secondary timepoints will be assessed during and after surgery
Onderzoeksproduct en/of interventie
Patients will be divided in several groups and receive either 5 or 10 mg ICG, administered (iv)30 min, 2h, 4h, 6h or 24 hours prior to surgery. Standard laparoscopic cholecystectomy will be performed. Fluorescence imaging will be frequently performed during surgery using the Karl Storz HD fluorescence laparoscope.
Publiek
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
Wetenschappelijk
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)
Patients (>18 years old) suffering from benign gallbladder pathology, planned to undergo laparoscopic cholecystectomy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allergy for jodide or indocyanine green;
2. Hyperthyroidism or autonomous thyroidal adenoma;
3. Pregnancy;
4. Severe renal impairment (eGFR<55)
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5488 |
| NTR-old | NTR5623 |
| Ander register | Addendum U : P10.001 |