Fluorescent near-infrared imaging can accurately detect bilary antomy during laparoscopic cholecystectomy.
ID
Bron
Verkorte titel
Aandoening
cholecystolithiasis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome parameter is the number of identified bile ducts.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Fluorescent near-infrared imaging can accurately detect bilary antomy during laparoscopic cholecystectomy.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery.
Onderzoeksproduct en/of interventie
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.
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)
1. Patients scheduled to undergo laparoscopic cholecystectomy;METC LUMC
2. Age above 18.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3530 |
| NTR-old | NTR3686 |
| Ander register | METC LUMC : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |