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Fluorescentiebeeldvorming van de galwegen tijdens kijkoperaties van de galblaas.


- candidate number10749
- NTR NumberNTR3211
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2011
- Secondary IDs11-2-078 / NL38521.068.11; METC azm/UM / CCMO
- Public TitleFluorescentiebeeldvorming van de galwegen tijdens kijkoperaties van de galblaas.
- Scientific TitleReal-time intraoperative near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy: A pilot study.
- ACRONYMNIRFC-LC
- hypothesisImproved and earlier identification of extra-hepatic bile ducts by intraoperative fluorescence imaging.
- Healt Condition(s) or Problem(s) studiedLaparoscopic cholecystectomy, Extra-hepatic bile ducts
- Inclusion criteria1. 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 criteria1. Liver or renal insufficiency;
2. History of allergy for iodine or indocyanine green;
3. Patient pregnant or lactating;
4. Aged < 18 years.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 14-dec-2011
- planned closingdate1-apr-2012
- Target number of participants10
- InterventionsStandard 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 outcomeFluorescence identification of extra-hepatic bile ducts, comparing the conventional white light image to the ICG image.
- Secondary outcome1. Fluorescence of bile ducts on different time points after injection;
2. Opinion of the surgeon regarding the application of fluorescence imaging during laparoscopic cholecystectomy.
- TimepointsPrimary and secondary outcomes will be assessed during (and after) surgical procedure.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. R.M. Schols
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L.P.S. Stassen
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryLaparoscopic 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:
30-oct-2012.

TARGET NUMBER OF PARTICIPANTS:
30.

INTERVENTIONS (addition):
Repeat intravenous ICG injection at establishment of critical view of safety for simultaneous fluorescence imaging of bile ducts and arterial anatomy.

PRIMARY OUTCOME:
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.
- RECORD22-dec-2011 - 7-nov-2012


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