CholecystitisNCT02344654
Fluorescence Cholangiography During Cholecystectomy - a RCT
A study testing Indocyanine green, Near-infrared illumination and Urografin in people with Cholecystitis and Gallstones, run by Hvidovre University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Gallstones
- What is being tested?
- Indocyanine green, Near-infrared illumination and Urografin
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
- Complicated gallstone disease
Who cannot join
- 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
About this study
Official title: Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
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.
- Conditions
- Cholecystitis, Gallstones
- Being tested
- Indocyanine green, Near-infrared illumination, Urografin, X-ray
- Keywords
- Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic
- Medical subject headings
- Cholecystitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Near-infrared illuminationDevice
To see the fluorescence from indocyanine green
UrografinDrug
X-rayRadiation
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence cholangiography | Experimental | 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. Receives: Drug: Indocyanine green; Device: Near-infrared illumination |
| X-ray cholangiography | Active comparator | 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. Receives: Drug: Urografin; Radiation: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Measured: Intraoperative
Secondary outcomes (4)
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Measured: Intraoperative
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Measured on a 5 point VAS scale
Measured: Intraoperative
Per-/postoperative adverse events as a measure of safety and tolerability
Measured: Intraoperative
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Measured: Admission to discharge from hospital (0-30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 May 2015
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lang Lehrskov, Hvidovre University Hospital
- Investigators
- Lars ML Lehrskov-Schmidt, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344654
- Sponsor's protocol ID
- 2015-HVH-LLS-01
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32057103Lehrskov 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.
PubMed 27477798
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
- ClinicalTrials.gov ID
- NCT02344654
- Acronym / sponsor ID
- 2015-HVH-LLS-01
- Conditions
- Cholecystitis, Gallstones
- Keywords
- Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence cholangiography | Experimental | Drug: Indocyanine green, Device: Near-infrared illuminationAfter 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. |
| X-ray cholangiography | Active comparator | Drug: Urografin, Radiation: X-rayThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
- Complicated gallstone disease
Key exclusion criteria (7 listed)
- Open cholecystectomy
- Allergy towards iodine, urografin or indocyanine green
- Liver or renal insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green | Drug | Fluorescence cholangiography |
| Near-infrared illuminationTo see the fluorescence from indocyanine green | Device | Fluorescence cholangiography |
| Urografin | Drug | X-ray cholangiography |
| X-ray | Radiation | X-ray cholangiography |
Primary outcome
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Time frame: Intraoperative
4 secondary outcomes
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Time frame: Intraoperative
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Time frame: Intraoperative
Per-/postoperative adverse events as a measure of safety and tolerability
Time frame: Intraoperative
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Time frame: Admission to discharge from hospital (0-30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 32057103Lehrskov 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.
- Derived from this study: PubMed 27477798Lehrskov 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.
Related trials for Cholecystitis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars ML Lehrskov-Schmidt, MD principal investigator
Hvidovre University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green, Near-infrared illumination and Urografin in people with Cholecystitis and Gallstones, run by Hvidovre University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of the cystic duct - common hepatic duct - common bile duct junction (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344654, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.