Clinical trial NCT06573021: Fluorescent Cholangiography in Acute Cholecystitis
Official title: The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: acute cholecystitis
emergency laparoscopic cholecystectomy
near-infrared fluorescent cholangiography
AAST classification
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy
timeFrame: From start of surgery to the end of Calot's triangle dissection
Secondary outcomes:
measure: Conversion rate in emergency cholecystectomy by fluorescence
timeFrame: perioperatively
measure: The bail-out procedures rate in emergency cholecystectomy by fluorescence
timeFrame: perioperatively
measure: The rate of bile duct injuries in emergency cholecystectomy by fluorescence
timeFrame: perioperatively
measure: The duration of surgery in emergency cholecystectomy by fluorescence
timeFrame: perioperatively
measure: Analysis of post-operative complications in emergency cholecystectomy by fluorescence
timeFrame: up to 30 days
measure: The length of stay in emergency cholecystectomy by fluorescence
timeFrame: perioperatively
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Unità Operativa Qualità, Accreditamento, Ricerca organizzativa
Study officials:
affiliation: Università degli Studi di Ferrara
name: ANTONIO AP PESCE, MD PhD FACS
role: STUDY_DIRECTOR
References:
citation: She WH, Cheung TT, Chan MY, Chu KW, Ma KW, Tsang SHY, Dai WC, Chan ACY, Lo CM. Routine use of ICG to enhance operative safety in emergency laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2022 Jun;36(6):4442-4451. doi: 10.1007/s00464-021-08795-2. Epub 2022 Feb 22.
citation: Wang X, Teh CSC, Ishizawa T, Aoki T, Cavallucci D, Lee SY, Panganiban KM, Perini MV, Shah SR, Wang H, Xu Y, Suh KS, Kokudo N. Consensus Guidelines for the Use of Fluorescence Imaging in Hepatobiliary Surgery. Ann Surg. 2021 Jul 1;274(1):97-106. doi: 10.1097/SLA.0000000000004718.
citation: Hernandez M, Murphy B, Aho JM, Haddad NN, Saleem H, Zeb M, Morris DS, Jenkins DH, Zielinski M. Validation of the AAST EGS acute cholecystitis grade and comparison with the Tokyo guidelines. Surgery. 2018 Apr;163(4):739-746. doi: 10.1016/j.surg.2017.10.041. Epub 2018 Jan 8.
citation: Pesce A, La Greca G, Esposto Ultimo L, Basile A, Puleo S, Palmucci S. Effectiveness of near-infrared fluorescent cholangiography in the identification of cystic duct-common hepatic duct anatomy in comparison to magnetic resonance cholangio-pancreatography: a preliminary study. Surg Endosc. 2020 Jun;34(6):2715-2721. doi: 10.1007/s00464-019-07158-2. Epub 2019 Oct 9.
citation: Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989.
citation: Pesce A, Palmucci S, La Greca G, Puleo S. Iatrogenic bile duct injury: impact and management challenges. Clin Exp Gastroenterol. 2019 Mar 6;12:121-128. doi: 10.2147/CEG.S169492. eCollection 2019.