Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Gall Stone Disease Clinical Trial

Official title:

Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136095
• Other study ID #: IFC_Feasibility_study
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: May 8, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Stone Disease
• Gallstones

Intervention

Procedure:
• Intraoperative fluorescent cholangiography (IFC)
A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No