|- candidate number||13283|
|- NTR Number||NTR3598|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2012|
|- Secondary IDs||2012/250, 2012/129 METC VUmc|
|- Public Title||Onderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens de operatie voor het verwijderen van de galblaas.|
|- Scientific Title||Pilot serie for visualisation of the common bile duct with indocyanine green during laparoscopic cholecystectomie with a near-infrared camera.|
|- hypothesis||Peroperative fluorescence of the bile ducts will improve visibility and result in early identification of the common bile duct and cystic duct during laparoscopic cholecystectomy.|
|- Healt Condition(s) or Problem(s) studied||Laparoscopy, Cholecystectomy, Bile ducts, Bile duct injury, Infrared|
|- Inclusion criteria||Diagnosis of symptomatic cholecystolithiasis with consistent physical examination, blood work and ultrasound. |
|- Exclusion criteria||1. Use of listed medication: anti-epileptics, cyclopropane, bisulphite connexions, haloperidole, diamorphine, pethidine, morphine, nitrophurantoine, opium alkaloids, phenobarbital, phenylbutzaon, probenicid, metamizol, methadone, riphamycine or natriumbisulphite;|
2. Allergy to ICG or Iodine;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-jan-2014|
|- Target number of participants||40|
|- Interventions||Pre-operative patients receive 1 dosis of Indocyanine Green (ICG), a fluorescent contrast agent that is secreted in bile.|
Per-operative a near-infrared laparoscopic camera is used to visualize ICG in bile ducts. During the laparoscopic cholecystectomy, both the conventional and near-infrared camera will be used to identify the common bile duct and cystic duct.
|- Primary outcome||1. Time of identification of the common bile duct and cystic duct;|
2. Frequency of identification of the common bile duct and cystic duct.
|- Secondary outcome||1. Detection of biliary and arterial anatomic variations;|
2. Prevention and detection of bile duct injuries.
|- Timepoints||Per-operative: ICG-NIR vs conventional identification of fluorescent bile structures:|
1. Before start of dissection;
2. Early during dissection;
3. Late during dissection;
4. At critical view of safety;
5. After completion of cholecystectomy.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. D.A. Dam, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. D.A. Dam, van|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Introduction: |
Injuries to the CBD are rare but serious complications with need for re-intervention, risk of permanent disability and prolonged hospital stay, and occur most often in presence of unclear or anatomic variations. An intra-operative cholangiogram requires additional operating time, a X-ray machine with trained personnel, and the bile ducts need to be cannulated to administer the contrast fluid to the biliary structures. Indocyanine Green (ICG) is a well used green contrast fluid, and with the recent introduction of a near-infrared (NIR) camera (Olympus, Hamburg Germany) can be used for its fluorescent qualities. After intravenous administration ICG is exclusively cleared by the liver and secreted into the bile, where it can be visualized with the near-infrared camera.
Patients eligible for elective laparoscopic cholecystectomy diagnosed with uncomplicated cholecystolithasis are included in the study. A intravenous injection of ICG is administered before induction of general anesthesia. During standard laparoscopic cholecystectomy, the NIR camera is used to visualize the biliary structures. When Critical View of Safety can not be obtained, a second intravenous injection of ICG can be administered at the surgeonís discretion to visualize the cystic artery. Post-operatively patients are admitted to the day-care centre and are discharged conform standard surgical procedures.
|- Main changes (audit trail)|
|- RECORD||4-sep-2012 - 6-okt-2012|