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Real-time intraoperatieve nabij-infrarode fluorescentie cholangiografie tijdens laparoscopische cholecystectomie.

Intra-operative fluorescent imaging of bile ducts during laparoscopic cholecystecomy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25103
Enrollment
15
Registered
2012-11-05
Start date
2012-03-01
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

cholecystolithiasis

Interventions

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 syst

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo laparoscopic cholecystectomy;METC LUMC 2. Age above 18.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Primary outcome parameter is the number of identified bile ducts.

Secondary

MeasureTime frame
Secundary parameters are the signal-to-background ratios measured in patients that recieved ICG, and the number of identified structures of the biliray tree.

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)