Fluorescent Cholangiography in Acute Cholecystitis

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Patients with a clinical and radiological diagnosis of acute cholecystitis	Near-infrared fluorescent cholangiography	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy	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 Outcome Measures

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

Locations (1): Unità Operativa Qualità, Accreditamento, Ricerca organizzativa
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Ferrara, Italy