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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate in emergency cholecystectomy by fluorescence | Conversion rate (from laparoscopy to open approach) | perioperatively |
| The bail-out procedures rate in emergency cholecystectomy by fluorescence |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| ANTONIO AP PESCE, MD PhD FACS | Università degli Studi di Ferrara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità Operativa Qualità , Accreditamento, Ricerca organizzativa | Ferrara | 44123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35194663 | Background | 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. | |
| 33351457 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2021 | Aug 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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Bail-out procedures during surgery, such as subtotal cholecystectomy, antegrade cholecystectomy
| perioperatively |
| The rate of bile duct injuries in emergency cholecystectomy by fluorescence | Iatrogenic bile duct injuries | perioperatively |
| The duration of surgery in emergency cholecystectomy by fluorescence | Total surgery duration (minutes) | perioperatively |
| Analysis of post-operative complications in emergency cholecystectomy by fluorescence | Postoperative complications according to Clavien-Dindo classification | up to 30 days |
| The length of stay in emergency cholecystectomy by fluorescence | Length of hospital stay | perioperatively |
| 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. |
| 29325783 | 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. |
| 31598878 | 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. |
| 34629815 | 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. |
| 30881079 | 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. |
| 39806739 | Derived | 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. |