Fluorescent Cholangiography in Acute Cholecystitis

August 23, 2024 updated by: Carlo Feo, University Hospital of Ferrara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44123
        • Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients aged >18 years-old with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines 2018 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients fit for surgery with ASA score of 0-3.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a clinical and radiological diagnosis of acute cholecystitis
Patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised Tokyo guidelines who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms and patients with American Society of Anesthesiologists (ASA) score of 0-3. Near-infrared fluorescent cholangiography was performed at three time points 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.
Drug: Near-infrared fluorescent cholangiography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From start of surgery to the end of Calot's triangle dissection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate in emergency cholecystectomy by fluorescence
Time Frame: perioperatively
Conversion rate (from laparoscopy to open approach)
perioperatively
The bail-out procedures rate in emergency cholecystectomy by fluorescence
Time Frame: perioperatively
Bail-out procedures during surgery, such as subtotal cholecystectomy, antegrade cholecystectomy
perioperatively
The rate of bile duct injuries in emergency cholecystectomy by fluorescence
Time Frame: perioperatively
Iatrogenic bile duct injuries
perioperatively
The duration of surgery in emergency cholecystectomy by fluorescence
Time Frame: perioperatively
Total surgery duration (minutes)
perioperatively
Analysis of post-operative complications in emergency cholecystectomy by fluorescence
Time Frame: up to 30 days
Postoperative complications according to Clavien-Dindo classification
up to 30 days
The length of stay in emergency cholecystectomy by fluorescence
Time Frame: perioperatively
Length of hospital stay
perioperatively

Collaborators and Investigators

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

Sponsor

University Hospital of Ferrara

Investigators

  • Study Director: ANTONIO AP PESCE, MD PhD FACS, Università degli Studi di Ferrara

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)

January 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1032/2021/Oss/AUSLFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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