No registrations found.
ID
Source
Brief title
Health condition
intraoperative clarification of bile duct anatomy using NIR fluorescence imaging
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Identification of bile ducts using laparoscopic NIR fluorescence imaging during laparoscopic cholecystectomy.
Secondary outcome
-Distinctive character of fluorescence imaging of bile ducts vs. liver after injection of either 5 or 10 mg ICG after several time points
-Evaluation of applicability of NIR fluorescence imaging during laparoscopic cholecystectomy by performing questionnaire after surgery
Background summary
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.
Study objective
Delayed fluorescence imaging is optimal for visualization of bile ducts compared to the surrounding liver.
Study design
The primary and secondary timepoints will be assessed during and after surgery
Intervention
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.
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
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
Inclusion criteria
Patients (>18 years old) suffering from benign gallbladder pathology, planned to undergo laparoscopic cholecystectomy
Exclusion criteria
1. Allergy for jodide or indocyanine green;
2. Hyperthyroidism or autonomous thyroidal adenoma;
3. Pregnancy;
4. Severe renal impairment (eGFR<55)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5488 |
| NTR-old | NTR5623 |
| Other | Addendum U : P10.001 |