Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial

Ausra Aleknaite, Gintaras Simutis, Juozas Stanaitis, Tomas Jucaitis, Mantas Drungilas, Jonas Valantinas, Kestutis Strupas, Ausra Aleknaite, Gintaras Simutis, Juozas Stanaitis, Tomas Jucaitis, Mantas Drungilas, Jonas Valantinas, Kestutis Strupas

Abstract

Background: The optimal approach for patients with gallbladder stones and intermediate risk of choledocholithiasis remains undetermined. The use of endoscopic retrograde cholangiopancreatography for diagnosis should be minimized as it carries considerable risk of postprocedural complications, and nowadays, less invasive and safer techniques are available.

Objective: This study compares the two management strategies of endoscopic ultrasound before laparoscopic cholecystectomy and intraoperative cholangiography for patients with symptomatic cholecystolithiasis and intermediate risk of choledocholithiasis.

Methods: This is a randomized, active-controlled, single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy for symptomatic gallbladder stones with intermediate risk of choledocholithiasis. The risk of choledocholithiasis is calculated using an original prognostic score (the Vilnius University Hospital Index). This index in a retrospective evaluation showed better prognostic performance than the score proposed by the American Society for Gastrointestinal Endoscopy in 2010. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm ("endoscopy first"). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be performed in another arm ("cholecystectomy first"). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. The secondary endpoints are accuracy of the different management strategies, adverse events of the interventions, duct clearance and technical success of the interventions (intraoperative cholangiography, endoscopic ultrasound, and endoscopic retrograde cholangiography), and cost of treatment.

Results: The trial protocol was approved by the Vilnius Regional Biomedical Research Ethics Committee in December 2017. Enrollment of patients was started in January 2018. As of June 2020, 66 patients have been enrolled.

Conclusions: This trial is planned to determine the superior strategy for patients with intermediate risk of common bile duct stones and to define a simple and safe algorithm for managing choledocholithiasis.

Trial registration: ClinicalTrials.gov NCT03658863; https://ichgcp.net/clinical-trials-registry/NCT03658863.

International registered report identifier (irrid): DERR1-10.2196/18837.

Keywords: choledocholithiasis; common bile duct stone; endoscopic retrograde cholangiopancreatography; endoscopic ultrasound; intraoperative cholangiography; laparoscopic cholecystectomy.

Conflict of interest statement

Conflicts of Interest: None declared.

©Ausra Aleknaite, Gintaras Simutis, Juozas Stanaitis, Tomas Jucaitis, Mantas Drungilas, Jonas Valantinas, Kestutis Strupas. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.02.2021.

References

    1. Dasari BVM, Tan CJ, Gurusamy KS, Martin DJ, Kirk G, McKie L, Diamond T, Taylor MA. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev. 2013 Dec 12;(12):CD003327. doi: 10.1002/14651858.CD003327.pub4.
    1. Costi R, Gnocchi A, Di Mario F, Sarli L. Diagnosis and management of choledocholithiasis in the golden age of imaging, endoscopy and laparoscopy. World J Gastroenterol. 2014 Oct 07;20(37):13382–401. doi: 10.3748/wjg.v20.i37.13382.
    1. Freeman ML. Complications of endoscopic retrograde cholangiopancreatography: avoidance and management. Gastrointest Endosc Clin N Am. 2012 Jul;22(3):567–86. doi: 10.1016/j.giec.2012.05.001.
    1. Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M, British Society of Gastroenterology Guidelines on the management of common bile duct stones (CBDS) Gut. 2008 Jul;57(7):1004–21. doi: 10.1136/gut.2007.121657.
    1. ASGE Standards of Practice Committee. Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1–9. doi: 10.1016/j.gie.2009.09.041.
    1. Adams MA, Hosmer AE, Wamsteker EJ, Anderson MA, Elta GH, Kubiliun NM, Kwon RS, Piraka CR, Scheiman JM, Waljee AK, Hussain HK, Elmunzer BJ. Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends. Gastrointest Endosc. 2015 Jul;82(1):88–93. doi: 10.1016/j.gie.2014.12.023.
    1. Prachayakul V, Aswakul P, Bhunthumkomol P, Deesomsak M. Diagnostic yield of endoscopic ultrasonography in patients with intermediate or high likelihood of choledocholithiasis: a retrospective study from one university-based endoscopy center. BMC Gastroenterol. 2014 Sep 26;14:165. doi: 10.1186/1471-230X-14-165.
    1. Suarez AL, LaBarre NT, Cotton PB, Payne KM, Coté GA, Elmunzer BJ. An assessment of existing risk stratification guidelines for the evaluation of patients with suspected choledocholithiasis. Surg Endosc. 2016 Oct;30(10):4613–8. doi: 10.1007/s00464-016-4799-8.
    1. Sethi S, Wang F, Korson AS, Krishnan S, Berzin TM, Chuttani R, Pleskow DK, Sawhney MS. Prospective assessment of consensus criteria for evaluation of patients with suspected choledocholithiasis. Dig Endosc. 2016 Jan;28(1):75–82. doi: 10.1111/den.12506.
    1. Rubin MIN, Thosani NC, Tanikella R, Wolf DS, Fallon MB, Lukens FJ. Endoscopic retrograde cholangiopancreatography for suspected choledocholithiasis: testing the current guidelines. Dig Liver Dis. 2013 Sep;45(9):744–9. doi: 10.1016/j.dld.2013.02.005.
    1. Aleknaite A, Simutis G, Stanaitis J, Valantinas J, Strupas K. Risk assessment of choledocholithiasis prior to laparoscopic cholecystectomy and its management options. United European Gastroenterol J. 2018 Apr 06;6(3):428–438. doi: 10.1177/2050640617731262. doi: 10.1177/2050640617731262.
    1. Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Büchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan S, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen X, Jagannath P, Lee SG, Padbury R, Chen M, Dervenis C, Chan ACW, Supe AN, Liau KH, Kim MH, Kim SW, Tokyo Guidelines Revision Committee TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos) J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24–34. doi: 10.1007/s00534-012-0561-3.
    1. Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Garden OJ, Kiriyama S, Hata J, Gabata T, Yoshida M, Miura F, Okamoto K, Tsuyuguchi T, Itoi T, Yamashita Y, Dervenis C, Chan AC, Lau W, Supe AN, Belli G, Hilvano SC, Liau K, Kim M, Kim S, Ker C, Tokyo Guidelines Revision Committee TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos) J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):35–46. doi: 10.1007/s00534-012-0568-9.
    1. Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS, Acute Pancreatitis Classification Working Group Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102–11. doi: 10.1136/gutjnl-2012-302779.
    1. . [2021-01-08].
    1. Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointestinal Endoscopy. 1991 May;37(3):383–393. doi: 10.1016/s0016-5107(91)70740-2.
    1. Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446–54. doi: 10.1016/j.gie.2009.10.027.
    1. Dindo D, Demartines N, Clavien P. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205–13. doi: 10.1097/.
    1. Almadi MA, Barkun JS, Barkun AN. Management of suspected stones in the common bile duct. CMAJ. 2012 May 15;184(8):884–92. doi: 10.1503/cmaj.110896.
    1. European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146–181. doi: 10.1016/j.jhep.2016.03.005.
    1. Meeralam Y, Al-Shammari K, Yaghoobi M. Diagnostic accuracy of EUS compared with MRCP in detecting choledocholithiasis: a meta-analysis of diagnostic test accuracy in head-to-head studies. Gastrointest Endosc. 2017 Dec;86(6):986–993. doi: 10.1016/j.gie.2017.06.009.
    1. Giljaca V, Gurusamy KS, Takwoingi Y, Higgie D, Poropat G, Štimac D, Davidson BR. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography for common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;(2):CD011549. doi: 10.1002/14651858.CD011549.
    1. Montariol T, Msika S, Charlier A, Rey C, Bataille N, Hay JM, Lacaine F, Fingerhut A. Diagnosis of asymptomatic common bile duct stones: preoperative endoscopic ultrasonography versus intraoperative cholangiography--a multicenter, prospective controlled study. French Associations for Surgical Research. Surgery. 1998 Jul;124(1):6–13.
    1. Gurusamy K, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Štimac D, Davidson B. Endoscopic retrograde cholangiopancreatography versus intraoperative cholangiography for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;(2):CD010339. doi: 10.1002/14651858.CD010339.pub2.
    1. Chen Y, Martel M, Barkun AN. Choledocholithiasis: Should EUS replace MRCP in patients at intermediate risk? Gastrointest Endosc. 2017 Dec;86(6):994–996. doi: 10.1016/j.gie.2017.07.034.
    1. Barreras González JE, Torres Peña R, Ruiz Torres J, Martínez Alfonso MÁ, Brizuela Quintanilla R, Morera Pérez M. Endoscopic versus laparoscopic treatment for choledocholithiasis: a prospective randomized controlled trial. Endosc Int Open. 2016 Nov;4(11):E1188–E1193. doi: 10.1055/s-0042-116144.
    1. Lu J, Cheng Y, Xiong XZ, Lin YX, Wu SJ, Cheng NS. Two-stage vs single-stage management for concomitant gallstones and common bile duct stones. World J Gastroenterol. 2012 Jun 28;18(24):3156–66. doi: 10.3748/wjg.v18.i24.3156.
    1. Kageoka M, Watanabe F, Maruyama Y, Nagata K, Ohata A, Noda Y, Miwa I, Ikeya K. Long-term prognosis of patients after endoscopic sphincterotomy for choledocholithiasis. Dig Endosc. 2009 Jul;21(3):170–5. doi: 10.1111/j.1443-1661.2009.00880.x.
    1. Byrne MF, McLoughlin MT, Mitchell RM, Gerke H, Pappas TN, Branch MS, Jowell PS, Baillie J. The fate of patients who undergo "preoperative" ERCP to clear known or suspected bile duct stones. Surg Endosc. 2009 Jan;23(1):74–9. doi: 10.1007/s00464-008-9903-2.
    1. Vettoretto N, Arezzo A, Famiglietti F, Cirocchi R, Moja L, Morino M. Laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct. Cochrane Database Syst Rev. 2018 Apr 11;4:CD010507. doi: 10.1002/14651858.CD010507.pub2.
    1. Ricci C, Pagano N, Taffurelli G, Pacilio CA, Migliori M, Bazzoli F, Casadei R, Minni F. Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi: A Systematic Review and Network Meta-analysis. JAMA Surg. 2018 Jul 18;153(7):e181167. doi: 10.1001/jamasurg.2018.1167.
    1. ElGeidie AA. Single-session minimally invasive management of common bile duct stones. World J Gastroenterol. 2014 Nov 07;20(41):15144–52. doi: 10.3748/wjg.v20.i41.15144.
    1. Mallick R, Rank K, Ronstrom C, Amateau SK, Arain M, Attam R, Freeman ML, Harmon JV. Single-session laparoscopic cholecystectomy and ERCP: a valid option for the management of choledocholithiasis. Gastrointest Endosc. 2016 Oct;84(4):639–45. doi: 10.1016/j.gie.2016.02.050.
    1. Baucom RB, Feurer ID, Shelton JS, Kummerow K, Holzman MD, Poulose BK. Surgeons, ERCP, and laparoscopic common bile duct exploration: do we need a standard approach for common bile duct stones? Surg Endosc. 2016 Feb;30(2):414–423. doi: 10.1007/s00464-015-4273-z.
    1. Masoni L, Mari FS, Pietropaolo V, Onorato M, Meucci M, Brescia A. Laparoscopic treatment for unsuspected common bile duct stones by transcystic sphincter of Oddi pneumatic balloon dilation and pressure-washing technique. World J Surg. 2013 Jun;37(6):1258–62. doi: 10.1007/s00268-013-1992-y.
    1. Hamouda AH, Goh W, Mahmud S, Khan M, Nassar AHM. Intraoperative cholangiography facilitates simple transcystic clearance of ductal stones in units without expertise for laparoscopic bile duct surgery. Surg Endosc. 2007 Jun 7;21(6):955–9. doi: 10.1007/s00464-006-9127-2.
    1. Mahmud S, McGlinchey I, Kasem H, Nassar A. Radiological treatment of retained bile duct stones following recent surgery using glucagons. Surg Endosc. 2001 Nov;15(11):1359–60. doi: 10.1007/s00464-001-4207-9.
    1. Simutis G. Disertacija biomedicinos mokslų daktaro laipsniui įgyti. Vilnius: Vilniaus Universitetas; 1998. Tulžies pūslės ir lydinčio tulžies latakų akmenligės gydymas minimaliai invaziniais chirurginiais būdais; p. 135.
    1. Perret R, Sloop G, Borne J. Common bile duct measurements in an elderly population. J Ultrasound Med. 2000 Nov;19(11):727–30; quiz 731. doi: 10.7863/jum.2000.19.11.727.
    1. Nárvaez Rivera RM, González González JA, Monreal Robles R, García Compean D, Paz Delgadillo J, Garza Galindo AA, Maldonado Garza HJ. Accuracy of ASGE criteria for the prediction of choledocholithiasis. Rev Esp Enferm Dig. 2016 Jun;108(6):309–14. doi: 10.17235/reed.2016.4212/2016.
    1. Magalhães J, Rosa B, Cotter J. Endoscopic retrograde cholangiopancreatography for suspected choledocholithiasis: From guidelines to clinical practice. World J Gastrointest Endosc. 2015 Feb 16;7(2):128–34. doi: 10.4253/wjge.v7.i2.128.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner