Fluorescent Cholangiography in Acute Cholecystitis

NCT06573021 | Completed

• 1 other identifier: 1032/2021/Oss/AUSLFe
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis; emergency laparoscopic cholecystectomy; near-infrared fluorescent cholangiography; AAST classification

Outcome Measures

Primary Outcomes (1)

• Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy

  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 Outcomes (6)

• Conversion rate in emergency cholecystectomy by fluorescence

  perioperatively

• The bail-out procedures rate in emergency cholecystectomy by fluorescence

  perioperatively

• The rate of bile duct injuries in emergency cholecystectomy by fluorescence

  perioperatively

• The duration of surgery in emergency cholecystectomy by fluorescence

  perioperatively

• Analysis of post-operative complications in emergency cholecystectomy by fluorescence

  up to 30 days

Study Arms (1)

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

Interventions

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.

Patients with a clinical and radiological diagnosis of acute cholecystitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Ferrara, 44123, Italy

Location

Related Publications (7)

• 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.

  PMID: 35194663 BACKGROUND

• 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.

  PMID: 33351457 BACKGROUND

• 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.

  PMID: 29325783 BACKGROUND

• 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.

  PMID: 31598878 BACKGROUND

• 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.

  PMID: 34629815 BACKGROUND

• 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.

  PMID: 30881079 BACKGROUND

• Pesce A, Fabbri N, Bonazza L, Feo C. The role of fluorescent cholangiography to improve operative safety in different severity degrees of acute cholecystitis during emergency laparoscopic cholecystectomy: a prospective cohort study. Int J Surg. 2024 Dec 1;110(12):7775-7781. doi: 10.1097/JS9.0000000000002160.

  PMID: 39806739 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• ANTONIO AP PESCE, MD PhD FACS

  Università degli Studi di Ferrara

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)