Fluorescence Cholangiography During Cholecystectomy - a RCT

February 26, 2024 updated by: Lars Lang Lehrskov, Hvidovre University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluorescence cholangiography
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 green
Device: Near-infrared illumination
To see the fluorescence from indocyanine green
Active Comparator: X-ray cholangiography
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: Urografin
Radiation: X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visualization of the cystic duct - common hepatic duct - common bile duct junction
Time Frame: Intraoperative
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography
Time Frame: Intraoperative
Intraoperative
Surgeon satisfaction score (Measured on a 5 point VAS scale)
Time Frame: Intraoperative
Measured on a 5 point VAS scale
Intraoperative
Per-/postoperative adverse events as a measure of safety and tolerability
Time Frame: Intraoperative
Intraoperative
Total cost of operation incl fluorescent/conventional X-ray cholangiography
Time Frame: Admission to discharge from hospital (0-30 days)
Admission to discharge from hospital (0-30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Lars ML Lehrskov-Schmidt, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

August 27, 2018

Study Completion (Actual)

August 27, 2018

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 18, 2015

First Posted (Estimated)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-HVH-LLS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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