Back to resultsFluorescence Cholangiography During Cholecystectomy - a RCT
Primary Purpose
Cholecystitis, Gallstones
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indocyanine green
Near-infrared illumination
Urografin
X-ray
Sponsored by
About this trial
This is an interventional prevention trial for Cholecystitis focused on measuring Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic
Eligibility Criteria
Inclusion Criteria:
- Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
- Complicated gallstone disease
Exclusion Criteria:
- Open cholecystectomy
- Allergy towards iodine, urografin or indocyanine green
- Liver or renal insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Legally incompetent for any reason
- Withdrawal of inclusion consent at any time
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluorescence cholangiography
X-ray cholangiography
Arm Description
After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.
The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner.
Outcomes
Primary Outcome Measures
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Secondary Outcome Measures
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Measured on a 5 point VAS scale
Per-/postoperative adverse events as a measure of safety and tolerability
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Full Information
NCT ID
NCT02344654
First Posted
January 9, 2015
Last Updated
October 2, 2018
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02344654
Brief Title
Fluorescence Cholangiography During Cholecystectomy - a RCT
Official Title
Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Gallstones
Keywords
Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluorescence cholangiography
Arm Type
Experimental
Arm Description
After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.
Arm Title
X-ray cholangiography
Arm Type
Active Comparator
Arm Description
The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Type
Device
Intervention Name(s)
Near-infrared illumination
Intervention Description
To see the fluorescence from indocyanine green
Intervention Type
Drug
Intervention Name(s)
Urografin
Intervention Type
Radiation
Intervention Name(s)
X-ray
Primary Outcome Measure Information:
Title
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Time Frame
Intraoperative
Title
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Description
Measured on a 5 point VAS scale
Time Frame
Intraoperative
Title
Per-/postoperative adverse events as a measure of safety and tolerability
Time Frame
Intraoperative
Title
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Time Frame
Admission to discharge from hospital (0-30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
Complicated gallstone disease
Exclusion Criteria:
Open cholecystectomy
Allergy towards iodine, urografin or indocyanine green
Liver or renal insufficiency
Thyrotoxicosis
Pregnancy or lactation
Legally incompetent for any reason
Withdrawal of inclusion consent at any time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars ML Lehrskov-Schmidt, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32057103
Citation
Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb 14.
Results Reference
derived
PubMed Identifier
27477798
Citation
Lehrskov LL, Larsen SS, Kristensen BB, Bisgaard T. Fluorescence versus X-ray cholangiography during laparoscopic cholecystectomy: protocol for a randomised trial. Dan Med J. 2016 Aug;63(8):A5261.
Results Reference
derived
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Fluorescence Cholangiography During Cholecystectomy - a RCT
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