Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Hvidovre University Hospital

Status: Completed

Conditions: Gall Stone Disease

Treatments: Procedure: Intraoperative fluorescent cholangiography (IFC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02136095

IFC_Feasibility_study

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

IFC-group

Experimental group

Description:

The investigators included patients undergoing laparoscopic cholecystectomy by a single surgeon between September and December 2013 at a single centre university department with unrestricted referral of patients. The included patients represented all patients undergoing laparoscopic cholecystectomy by one surgeon during the study period. All patients underwent intra-operative fluorescent cholangiography (IFC) with concomitant angiography, according to a standardized protocol, during their laparoscopic cholecystectomy.

Treatment:

Procedure: Intraoperative fluorescent cholangiography (IFC)