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OpenTrials
Completed

NCT Number: NCT02344654

Fluorescence Cholangiography During Cholecystectomy - a RCT

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.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

Near-infrared illumination

Device

To see the fluorescence from indocyanine green

Urografin

Drug

X-Ray

Radiation

Primary outcomes

  1. Visualization of the cystic duct - common hepatic duct - common bile duct junction

    Time frame: Intraoperative

Secondary outcomes

  1. Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography

    Time frame: Intraoperative

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

    Time frame: Intraoperative

    Measured on a 5 point VAS scale

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

    Time frame: Intraoperative

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

    Time frame: Admission to discharge from hospital (0-30 days)

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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