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Fluorescentiebeeldvorming van de galwegen tijdens kijkoperaties van de galblaas.

Real-time intraoperative near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy: A pilot study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27461
Enrollment
30
Registered
2011-12-22
Start date
2011-12-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

laparoscopic cholecystectomy, extra-hepatic bile ducts

Interventions

Standard laparoscopic cholecystectomy will be performed, after preoperative intravenous administration of the near-infrared fluorescence dye indocyanine green. Using a modified laparoscopic device (fo

Sponsors

Maastricht University Medical Centre (MUMC+)
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
12-09-2012: Change: Fluorescence identification of the extra-hepatic bile ducts and confirmation of the arterial anatomy, comparing the conventional white light image to the ICG image.

Secondary

MeasureTime frame
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.

Contacts

Public ContactR.M. Schols

P. Debyelaan 25

rutger.schols@mumc.nl+31 (0)43 3881575

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)