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Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136095
Enrollment
35
Registered
2014-05-12
Start date
2013-09-30
Completion date
2013-12-31
Last updated
2014-05-12

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

Conditions

Gall Stone Disease

Keywords

Fluorescent cholangiography, Laparoscopic cholecystectomy

Brief summary

Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures. Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.

Interventions

PROCEDUREIntraoperative fluorescent cholangiography (IFC)

A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Scheduled for acute- or elective laparoscopic cholecystectomy * Informed consent

Exclusion criteria

* Known iodine-hypersensitivity * Liver- or renal insufficiency * Known thyrotoxicosis * Pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
Time expenditure of IFC with concomitant angiography.Four monthsIntra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)

Secondary

MeasureTime frameDescription
Success-rate of the IFC-procedures.Four monthsThe operating surgeon completed a structured questionnaire immediately after each operation regarding anatomical identification by IFC (visible cystic duct, -common bile duct, -common hepatic duct, -right and left hepatic ducts, -cystic artery, -aberrant bile ducts, and/or other abnormalities). Successful IFC was defined as exposure of the junction between the cystic duct, common bile duct and common hepatic duct by IFC. Success-full fluorescent angiography was defined as adequate visualisation of the cystic artery within Calot´s triangle by the method.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026