Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Primary Purpose
Gall Stone Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intraoperative fluorescent cholangiography (IFC)
Sponsored by
About this trial
This is an interventional diagnostic trial for Gall Stone Disease focused on measuring Fluorescent cholangiography, Laparoscopic cholecystectomy
Eligibility Criteria
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
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IFC-group
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02136095
Brief Title
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Official Title
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stone Disease
Keywords
Fluorescent cholangiography, Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFC-group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative fluorescent cholangiography (IFC)
Intervention Description
A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.
Primary Outcome Measure Information:
Title
Time expenditure of IFC with concomitant angiography.
Description
Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Success-rate of the IFC-procedures.
Description
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.
Time Frame
Four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Larsen, MD, PhD
Organizational Affiliation
Gastroenheden, Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25162446
Citation
Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.
Results Reference
derived
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Promising Initial Experience With Intra-operative Fluorescent Cholangiography
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