Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Not Applicable

Completed

• Conditions: Gall Stone Disease
• Interventions: Procedure: Intraoperative fluorescent cholangiography (IFC)

• Registration Number: NCT02136095
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-08
• Last Update Submitted: 2014-05-08
• Study First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IFC-group	Intraoperative fluorescent cholangiography (IFC)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Success-rate of the IFC-procedures.	Four months	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.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark