NCT02344654

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.3 years

First QC Date

January 9, 2015

Last Update Submit

February 26, 2024

Conditions

CholecystitisGallstones

Keywords

FluorescenceCholangiographyIndocyanine GreenCholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (1)

  • Visualization of the cystic duct - common hepatic duct - common bile duct junction

    Intraoperative

Secondary Outcomes (4)

  • Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography

    Intraoperative

  • Surgeon satisfaction score (Measured on a 5 point VAS scale)

    Intraoperative

  • Per-/postoperative adverse events as a measure of safety and tolerability

    Intraoperative

  • Total cost of operation incl fluorescent/conventional X-ray cholangiography

    Admission to discharge from hospital (0-30 days)

Study Arms (2)

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.

Drug: Indocyanine greenDevice: 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.

Drug: UrografinRadiation: X-ray

Interventions

Indocyanine greenDRUG
Fluorescence cholangiography
Near-infrared illuminationDEVICE

To see the fluorescence from indocyanine green

Fluorescence cholangiography
UrografinDRUG
X-ray cholangiography
X-rayRADIATION
X-ray cholangiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
  • Complicated gallstone disease

You may not qualify if:

  • Open cholecystectomy
  • Allergy towards iodine, urografin or indocyanine green
  • Liver or renal insufficiency
  • Thyrotoxicosis
  • Pregnancy or lactation
  • Legally incompetent for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32057103RESULT

  • 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.

    PMID: 27477798DERIVED

MeSH Terms

Conditions

CholecystitisGallstones

Interventions

Indocyanine GreenDiatrizoate MeglumineX-Rays

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsDiatrizoateTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydratesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Lars ML Lehrskov-Schmidt, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 26, 2015

Study Start

May 1, 2015

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

February 28, 2024

Record last verified: 2024-02