Near infrared indocyanine green fluorescent cholangiography versus intraoperative cholangiography to improve safety in laparoscopic cholecystectomy for gallstone disease-a systematic review protocol

Mihai-Calin Pavel, Mar Achalandabaso Boira, Yasir Bashir, Robert Memba, Erik Llácer, Laia Estalella, Elisabeth Julià, Kevin C Conlon, Rosa Jorba, Mihai-Calin Pavel, Mar Achalandabaso Boira, Yasir Bashir, Robert Memba, Erik Llácer, Laia Estalella, Elisabeth Julià, Kevin C Conlon, Rosa Jorba

Abstract

Background: Laparoscopic cholecystectomy has become the standard surgical approach in the treatment of cholelithiasis. Diverse surgical techniques and different imaging modalities have been described to evaluate the biliary anatomy and prevent or early detect bile duct injuries. X-ray intraoperative cholangiography (IOC) and near infrared indocyanine green fluorescent cholangiography (NIR-ICG) are safe and feasible techniques to assess biliary anatomy. The aim of this systematic review will be to evaluate if NIR-ICG can visualize extrahepatic biliary anatomy more efficiently and safer than IOC in minimally invasive cholecystectomy for gallstone disease.

Methods: Literature search will be performed via MEDLINE (PubMed), Embase, Scopus, the Cochrane Central Register of Controlled Trials, and Web of Science Core Collection from 2009 to present. All randomized controlled clinical trials and prospective non-randomized controlled trials which report on comparison of NIR-ICG versus IOC will be included. All patients over 18 years old who require elective or urgent minimally invasive cholecystectomy (undergoing NIR-ICG during this procedure) due to gallstone disease both acute and chronic will be included. Since BDI has a low incidence, the primary outcome will be the ability to visualize extrahepatic biliary anatomy and the time to obtain relevant images of these structures. Two researchers will individually screen the identified records, according to a list of inclusion and exclusion criteria. Bias of the studies will be evaluated with the Newcastle-Ottawa score for non-randomized studies and with The Cochrane Risk of Bias Tool for randomized controlled trials. Quality of evidence for all outcomes will be determined with the GRADE system. The data will be registered in a predesigned database. If selected studies are sufficiently homogeneous, we will perform a meta-analysis of reported results. In the event of a substantial heterogeneity, a narrative synthesis will be provided. Subgroup analysis will be used to investigate possible sources of heterogeneity.

Discussion: Understanding the benefits of this technique is critical to ensuring policymakers can make informed decisions as to where preventive efforts should be focused regarding specific imaging techniques. If ICG is proven to be faster and non-invasive, its routine use could be encouraged.

Systematic review registration: PROSPERO CRD42020177991 .

Keywords: Bile duct injury; Cholecystectomy; Fluorescence; ICG; Indocyanine Green.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

References

    1. Eurostat . Surgical operations and procedures performed in hospitals by ICD-9-CM. 2019.
    1. Niwa UC, Axt S, Falch C, Müller S, Kreuzer JA, Nedela P, et al. Die laparoskopische Cholezystektomie als standardisierter Lehreingriff zur Behandlung der symptomatischen Cholezystolithiasis. Zentralblatt fur Chir - Zeitschrift fur Allg Visz und Gefasschirurgie. 2013;138(2):141–142.
    1. Grbas H, Kunisek L, Zelić M, Petrosić N, Cepić I, Pirjavec A, et al. Outcome evaluation of 10,317 laparoscopic cholecystectomies: a 17-year experience at a single center. Hepatogastroenterology. 2013;60(128):1873–1876.
    1. Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995;180:101–125.
    1. Berci G, Hunter J, Morgenstern L, Arregui M, Brunt M, Carroll B, et al. Laparoscopic cholecystectomy: first, do no harm; second, take care of bile duct stones. Surg Endosc. 2013;27:1051–1054.
    1. Halbert C, Pagkratis S, Yang J, Meng Z, Altieri MS, Parikh P, et al. Beyond the learning curve: incidence of bile duct injuries following laparoscopic cholecystectomy normalize to open in the modern era. Surg Endosc. 2016;30(6):2239–2243.
    1. Rystedt J, Lindell G, Montgomery A. Bile duct injuries associated with 55,134 cholecystectomies: treatment and outcome from a national perspective. World J Surg. 2016;40(1):73–80.
    1. Bektas H, Schrem H, Winny M, Klempnauer J. Surgical treatment and outcome of iatrogenic bile duct lesions after cholecystectomy and the impact of different clinical classification systems. Br J Surg. 2007;94(9):1119–1127.
    1. Ausania F, Holmes LR, Ausania F, Iype S, Ricci P, White SA. Intraoperative cholangiography in the laparoscopic cholecystectomy era: Why are we still debating? Surg Endosc. 2012;26:1193–1200.
    1. Diana M, Soler L, Agnus V, D’Urso A, Vix M, Dallemagne B, et al. Prospective evaluation of precision multimodal gallbladder surgery navigation: virtual reality, near-infrared fluorescence, and X-ray-based intraoperative cholangiography. Ann Surg. 2017;266(5):890–897.
    1. Berney CR. Major common bile duct injury and risk of litigation: a surgeon’s perspective. Am J Surg. 2012;204:800–802.
    1. Massarweh NN, Flum DR. Role of intraoperative cholangiography in avoiding bile duct injury. J Am Coll Surg. 2007;204:656–664.
    1. van de Graaf FW, Zaïmi I, Stassen LPSS, Lange JF, et al. Safe laparoscopic cholecystectomy: a systematic review of bile duct injury prevention. Int J Surg. 2018;60:164–172.
    1. Booij KAC, De Reuver PR, Nijsse B, Busch ORC, Van Gulik TM, Gouma DJ. Insufficient safety measures reported in operation notes of complicated laparoscopic cholecystectomies. Surg (United States) 2014;155(3):384–389.
    1. Deal SB, Stefanidis D, Telem D, Fanelli RD, McDonald M, Ujiki M, et al. Evaluation of crowd-sourced assessment of the critical view of safety in laparoscopic cholecystectomy. Surg Endosc. 2017;31(12):5094–5100.
    1. Nakajima J, Sasaki A, Obuchi T, Baba S, Nitta H, Wakabayashi G. Laparoscopic subtotal cholecystectomy for severe cholecystitis. Surg Today. 2009;39(10):870–875.
    1. Mirizzi PL. Operative cholangiography. Rev Esp Enferm Apar Dig Nutr. 1950;9(3):306–308.
    1. Ford JA, Soop M, Du J, Loveday BPT, Rodgers M. Systematic review of intraoperative cholangiography in cholecystectomy. Br J Surg. 2012;99(2):160–167.
    1. Ido K, Isoda N, Kawamoto C, Suzuki T, Ioka T, Nagamine N, et al. Confirmation of a “‘safety zone’” by intraoperative cholangiography during laparoscopic cholecystectomy. Surg Endosc. 1996;10(8):798–800.
    1. SAGES . Guidelines for the clinical application of laparoscopic biliary tract surgery. 2010.
    1. De’Angelis N, Catena F, Memeo R, Coccolini F, Martínez-Pérez A, Romeo OM, et al. 2020 WSES guidelines for the detection and management of bile duct injury during cholecystectomy. World J Emerg Surg. 2021;16(1):30.
    1. Ishizawa T, Tamura S, Masuda K, Aoki T, Hasegawa K, Imamura H, et al. Intraoperative fluorescent cholangiography using indocyanine green: a biliary road map for safe surgery. J Am Coll Surg. 2009;208(1):e1–e4.
    1. Cherrick GR, Stein SW, Leevy CM, Davidson CS. Indocyanine green: observations on its physical properties, plasma decay, and hepatic extraction. J Clin Invest. 1960;39:592–600.
    1. Takase S, Takada A, Matsuda Y. Studies on the pathogenesis of the constitutional excretory defect of indocyanine green. Gastroenterol Jpn. 1982;17(4):301–309.
    1. Alander JT, Kaartinen I, Laakso A, Pätilä T, Spillmann T, Tuchin VV, et al. A Review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:Article ID 940585, 26 pages. 10.1155/2012/940585.
    1. Pesce A, Piccolo G, La Greca G, Puleo S. Utility of fluorescent cholangiography during laparoscopic cholecystectomy: a systematic review. World J Gastroenterol. 2015;21(25):7877–7883.
    1. Zarrinpar A, Dutson EP, Mobley C, Busuttil RW, Lewis CE, Tillou A, et al. Intraoperative laparoscopic near-infrared fluorescence cholangiography to facilitate anatomical identification: when to give indocyanine green and how much. Surg Innov. 2016;23(4):360–365.
    1. Osayi SN, Wendling MR, Drosdeck JM, Chaudhry UI, Perry KA, Noria SF, et al. Near-infrared fluorescent cholangiography facilitates identification of biliary anatomy during laparoscopic cholecystectomy. Surg Endosc Other Interv Tech. 2015;29(2):368–375.
    1. Quaresima S, Balla A, Palmieri L, Seitaj A, Fingerhut A, Ursi P, et al. Routine near infra-red indocyanine green fluorescent cholangiography versus intraoperative cholangiography during laparoscopic cholecystectomy: a case-matched comparison. Surg Endosc. 2019;34(5):1959–1967.
    1. Mordon S, Devoisselle JM, Soulie-Begu S, Desmettre T. Indocyanine green: physicochemical factors affecting its fluorescence in vivo. Microvasc Res. 1998;55(2):146–152.
    1. Dip F, Roy M, Menzo E. Lo, Simpfendorfer C, Szomstein S, Rosenthal RJ, et al. Routine use of fluorescent incisionless cholangiography as a new imaging modality during laparoscopic cholecystectomy. Surg Endosc. 2015;29(6):1621–1626.
    1. Speich R, Saesseli B, Hoffmann U, Neftel KA, Reichen J. Anaphylactoid reactions after indocyanine-green administration. Ann Intern Med. 1988;109:345–346.
    1. Mitsuhashi N, Kimura F, Shimizu H, Imamaki M, Yoshidome H, Ohtsuka M, et al. Usefulness of intraoperative fluorescence imaging to evaluate local anatomy in hepatobiliary surgery. J Hepatobiliary Pancreat Surg. 2008;15(5):508–514.
    1. Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, et al. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015;29(7):2046–2055.
    1. Schols RM, Bouvy ND, van Dam RM, Masclee AAM, Dejong CHC, Stassen LPS. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013;27(12):4511–4517.
    1. Diana M, Soler L, Agnus V, D’Urso A, Vix M, Dallemagne B, et al. Prospective evaluation of precision multimodal gallbladder surgery navigation. Ann Surg. 2017;266(5):890–897.
    1. Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020;107(6):655–661. doi: 10.1002/bjs.11510.
    1. Roy M, Dip F, Nguyen D, Simpfendorfer CH, Menzo E. Lo, Szomstein S, et al. Fluorescent incisionless cholangiography as a teaching tool for identification of Calot’s triangle. Surg Endosc. 2017;31(6):2483–2490.
    1. Prevot F, Rebibo L, Cosse C, Browet F, Sabbagh C, Regimbeau J-M. Effectiveness of intraoperative cholangiography using indocyanine green (versus contrast fluid) for the correct assessment of extrahepatic bile ducts during day-case laparoscopic cholecystectomy. J Gastrointest Surg. 2014;18(8):1462–1468.
    1. Zroback C, Chow G, Meneghetti A, Warnock G, Meloche M, Chiu CJ, et al. Fluorescent cholangiography in laparoscopic cholecystectomy: the initial canadian experience. Am J Surg. 2016;211(5):933–937.
    1. Tagaya N, Sugamata Y, Makino N, Saito K, Okuyama T, Koketsu S, et al. Fluorescence cholangiography in laparoscopic cholecystectomy: Experience in Japan. Front Gastrointest Res. 2013;31:73–79.
    1. Dip FD, Nahmod M, Alle L, Sarotto L, Anzorena FS, Ferraina P. Fluorescence cholangiography in laparoscopic cholecystectomy experience in Argentina. Front Gastrointest Res. 2013;31:80–85.
    1. Livingston EH, Flum DR, Dellinger EP, Chan L. Intraoperative cholangiography and risk of common bile duct injury. JAMA. 2003;290:459.
    1. Massarweh NN, Devlin A, Elrod JAB, Symons RG, Flum DR. Surgeon knowledge, behavior, and opinions regarding intraoperative cholangiography. J Am Coll Surg. 2008;207(6):821–830.
    1. Lwin TM, Hoffman RM, Bouvet M. Fluorescence-guided hepatobiliary surgery with long and short wavelength fluorophores. Hepatobiliary Surg Nutr. 2020;9(5):615–39. 10.21037/hbsn.2019.09.13.
    1. Vlek SL, van Dam DA, Rubinstein SM, de lange-de Klerk ESM, Schoonmade LJ, Tuynman JB, et al. Biliary tract visualization using near-infrared imaging with indocyanine green during laparoscopic cholecystectomy: results of a systematic review. Surg Endosc Other Interv Tech. 2017;31(7):2731–2742.
    1. Dip F, Sarotto L, Roy M, Lee A, LoMenzo E, Walsh M, et al. Incisionless fluorescent cholangiography (IFC): a pilot survey of surgeons on procedural familiarity, practices, and perceptions. Surg Endosc. 2020;34(2):675–685.
    1. Slim K, Millat B. Routine or selective intraoperative cholangiography during laparoscopic cholecystectomy. Ann Chir. 2004;129:518–520.
    1. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1.
    1. Lehrskov LL, Larsen SS, Kristensen BB, Bisgaard T. Fluorescence versus X-ray cholangiography during laparoscopic cholecystectomy: protocol for a randomised trial. Dan Med J. 2016;63(8).
    1. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol. 2010;25:603–605.
    1. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. 10.1136/bmj.l4898.
    1. Review Manager Web (RevMan Web). Version 5.4.1. The Cochrane Collaboration, (September 2020). Available at .
    1. Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022.
    1. Campbell M, McKenzie JE, Sowden A, Katikireddi SV, Brennan SE, Ellis S, et al. Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline. BMJ. 2020;368:l6890. 10.1136/bmj.l6890.
    1. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315(7109):629–634.
    1. Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006;295(6):676–680.
    1. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–926.

Source: PubMed

3
購読する