|- candidate number||10749|
|- NTR Number||NTR3211|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-dec-2011|
|- Secondary IDs||11-2-078 / NL38521.068.11; METC azm/UM / CCMO|
|- Public Title||Fluorescentiebeeldvorming van de galwegen tijdens kijkoperaties van de galblaas.|
|- Scientific Title||Real-time intraoperative near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy: A pilot study.|
|- hypothesis||Improved and earlier identification of extra-hepatic bile ducts by intraoperative fluorescence imaging.|
|- Healt Condition(s) or Problem(s) studied||Laparoscopic cholecystectomy, Extra-hepatic bile ducts|
|- Inclusion criteria||1. Patients scheduled for a laparoscopic cholecystectomy;|
2. Males and females (not pregnant);
3. Age >18 years;
4. Normal liver and renal function;
5. No history of allergy for iodine or indocyanine green.
|- Exclusion criteria||1. Liver or renal insufficiency;|
2. History of allergy for iodine or indocyanine green;
3. Patient pregnant or lactating;
4. Aged < 18 years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||14-dec-2011|
|- planned closingdate||1-apr-2012|
|- Target number of participants||10|
|- Interventions||Standard laparoscopic cholecystectomy will be performed, after preoperative intravenous administration of the near-infrared fluorescence dye indocyanine green. Using a modified laparoscopic device (for both white light, and ICG imaging) the extra-hepatic bile ducts will be visualized non-invasively.|
|- Primary outcome||Fluorescence identification of extra-hepatic bile ducts, comparing the conventional white light image to the ICG image.|
|- Secondary outcome||1. Fluorescence of bile ducts on different time points after injection;|
2. Opinion of the surgeon regarding the application of fluorescence imaging during laparoscopic cholecystectomy.
|- Timepoints||Primary and secondary outcomes will be assessed during (and after) surgical procedure.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. R.M. Schols|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. L.P.S. Stassen|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief summary||Laparoscopic cholecystectomy is one of the most commonly performed endoscopic procedures in gastrointestinal surgery. Bile duct injury (BDI) during this surgery is rare but constitutes a serious complication (0.3-0.7%). Misidentification of biliary anatomy during laparoscopic cholecystectomy appears to be the largest cause of BDI. Intraoperative cholangiography (IOC) is advised to reduce the risk of BDI. However, this imaging technique is only used selectively. The process takes time, radiation exposure is involved and additional equipment and manpower for the proceedings are required. Moreover, worldwide consensus about the implementation of IOC is lacking.|
Fluorescence cholangiography with preoperative indocyanin green (ICG) administration is a promising new technique for easier intraoperative visualization of the biliary anatomy and thereby it could improve the outcome – safety and efficiency – of laparoscopic cholecystectomy.
Standard laparoscopic cholecystectomy will be performed, after preoperative intravenous administration of the near-infrared fluorescence dye indocyanine green. Using a modified laparoscopic device (for both conventional and fluorescence imaging) the extra-hepatic bile ducts will be visualized non-invasively.
|- Main changes (audit trail)||12-Sep-2012: Amendment.|
PLANNED CLOSING DATE:
TARGET NUMBER OF PARTICIPANTS:
Repeat intravenous ICG injection at establishment of critical view of safety for simultaneous fluorescence imaging of bile ducts and arterial anatomy.
Fluorescence identification of the extra-hepatic bile ducts and confirmation of the arterial anatomy, comparing the conventional white light image to the ICG image.
NUMBER OF PARTICIPANTS:
Patient inclusion expanded: from 10 to 30.
Additional intervention/observation in the last 20 patients: Simultaneous fluorescence imaging of the arterial anatomy at establishment of critical view of safety; after repeat ICG administration.
|- RECORD||22-dec-2011 - 7-nov-2012|