Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Study Overview
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Brief Summary
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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.

Official Title
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Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Conditions
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Gall Stone Disease

Intervention / Treatment
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* Procedure: Intraoperative fluorescent cholangiography (IFC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFC-group<br>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. | Procedure: Intraoperative fluorescent cholangiography (IFC)<br>* A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time expenditure of IFC with concomitant angiography. | Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013) | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success-rate of the IFC-procedures. | The 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. | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescent cholangiography, Laparoscopic cholecystectomy