No registrations found.
ID
Source
Brief title
Health condition
cholecystolithiasis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is the number of identified bile ducts.
Secondary outcome
Secundary parameters are the signal-to-background ratios measured in patients that recieved ICG, and the number of identified structures of the biliray tree.
Background summary
During laparoscopic cholecystectomy, common bile duct injury is a rare but severe complication. Optical imaging using near-infrared (NIR) fluorescence has recently been introduced to reduce the risk of injury by real time visual guidance. The aim of the current study is to optimize dose and timing of ICG for near-infrared cholangiography using laparoscopic fluorescence imaging system.
Study objective
Fluorescent near-infrared imaging can accurately detect bilary antomy during laparoscopic cholecystectomy.
Study design
The primary and secondary outcomes will be assessed during surgery.
Intervention
Standard laparoscopic cholecystecomy will be performed. During surgery, the near-infrared dye ICG will be injected and the bile ducts will be visualized non-invasively using a laparoscopic camera system.
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
1. Patients scheduled to undergo laparoscopic cholecystectomy;METC LUMC
2. Age above 18.
Exclusion criteria
1. History of allergy to iodine, shellfish, indocyanine green, human serum albumin and/or history of hyperthyroidism or severe renal impairment;METC LUMC
2. Patient pregnant or lactating.
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 | NL3530 |
| NTR-old | NTR3686 |
| Other | METC LUMC : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |