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Completed

NCT Number: NCT06573021

Fluorescent Cholangiography in Acute Cholecystitis

Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Ferrara, 44123, Italy

About this study

The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct and any accessory or aberrant ducts) in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma (AAST) classification, specifically distinguishing between non-gangrenous (grade I) and gangrenous or complicated (grades II-V) forms. For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery. All the operations were performed by the same team of surgeons. Near-infrared fluorescent cholangiography was performed by using Stryker's fluorescence imaging system (Stryker, Portage, Miami, USA). Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle, according to the "Critical View of Safety" method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised TG18 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms;
  • patients with ASA score of 1-3;

Exclusion criteria

  • patients with a known allergy to indocyanine green;
  • ASA score 4-5;
  • patients deemed non-operable via laparoscopic approach due to high cardio-respiratory risk;
  • previous surgical interventions on the biliary tract;
  • history of liver cirrhosis or severe liver disease;
  • ongoing pregnancy or breastfeeding.

Treatment and study plan

Near-infrared fluorescent cholangiography

Drug

For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG, Pulsion Medical Inc., Irving, Tx) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery (ISFGS) and the latest consensus conference published in 2021.

Primary outcomes

  1. Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy

    Time frame: From start of surgery to the end of Calot's triangle dissection

    The primary aim was to analyze the correct visualization by fluorescence of extrahepatic bile ducts (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct, and any accessory or aberrant ducts) before and after Calot's dissection in different grades of severity of acute cholecystitis according to the AAST classification, particularly distinguishing non-gangrenous forms (grade I) from gangrenous and complicated forms (grades II-V).

Secondary outcomes

  1. Conversion rate in emergency cholecystectomy by fluorescence

    Time frame: perioperatively

    Conversion rate (from laparoscopy to open approach)

  2. The bail-out procedures rate in emergency cholecystectomy by fluorescence

    Time frame: perioperatively

    Bail-out procedures during surgery, such as subtotal cholecystectomy, antegrade cholecystectomy

  3. The rate of bile duct injuries in emergency cholecystectomy by fluorescence

    Time frame: perioperatively

    Iatrogenic bile duct injuries

  4. The duration of surgery in emergency cholecystectomy by fluorescence

    Time frame: perioperatively

    Total surgery duration (minutes)

  5. Analysis of post-operative complications in emergency cholecystectomy by fluorescence

    Time frame: up to 30 days

    Postoperative complications according to Clavien-Dindo classification

  6. The length of stay in emergency cholecystectomy by fluorescence

    Time frame: perioperatively

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 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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