Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study

Jie-Gao Zhu, Shanshan Wu, Qiushi Feng, Fei Li, Wei Han, Dianrong Xiu, Haidong Tan, Jianzhu Fu, Xun Li, Dong Shang, Houbao Liu, Binglu Li, Li Yang, Yuanyuan Kong, Siyan Zhan, Wei Guo, Zhong-Tao Zhang, Jie-Gao Zhu, Shanshan Wu, Qiushi Feng, Fei Li, Wei Han, Dianrong Xiu, Haidong Tan, Jianzhu Fu, Xun Li, Dong Shang, Houbao Liu, Binglu Li, Li Yang, Yuanyuan Kong, Siyan Zhan, Wei Guo, Zhong-Tao Zhang

Abstract

Introduction: The best approach for choledocholithiasis remains a matter of debate. Choledocholithiasis is usually treated with endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) or laparoscopic transcystic common bile duct exploration (LTCBDE). Data pertaining to the clinical outcomes of these approaches in the management of patients with cholecysto-choledocholithiasis in China are limited. An analysis of the economic burden associated with these treatments is lacking. The Chinese REgistry Study on the Treatment of Cholecysto-Choledocholithiasis (CREST Choles) was designed to address these issues in a real-world setting.

Methods and analysis: CREST Choles was an ambispective, multicenter, observational, open-cohort study. A total of 2700 patients undergoing one of the three treatments (EST+laparoscopic cholecystectomy (LC), LCBDE+LC and LTCBDE+LC) during the period from 1 January 2013 to 1 December 2018 at participating centres were enrolled in the study. Patients with gallstones and confirmed common bile duct stones were included. Data pertaining to demographics, disease history, procedural details, imaging features and follow-up were collected. Follow-up was conducted at least 6 months after enrolment in the study and annual follow-up will be conducted until December 2020. The primary outcome is the rate of adverse outcomes within 3 years postoperatively. Economic analysis (eg, incremental cost-effectiveness ratio) would be performed to compare expense across treatments.

Ethics and dissemination: Ethical approval was obtained at all participating centres. The registry presented is the first attempt to comprehensively evaluate the cost of treatment for cholecysto-choledocholithiasis in China. Findings are expected to be available in 2020 and will facilitate clinical decision making in such cases.

Trial registration number: NCT02554097.

Keywords: change management; hepatobiliary disease; hepatobiliary surgery; quality in health care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Wang S, Kou C, Liu Y, et al. . Rural-urban differences in the prevalence of chronic disease in northeast China. Asia Pac J Public Health 2015;27:394–406. 10.1177/1010539514551200
    1. Chen L-Y, Qiao Q-H, Zhang S-C, et al. . Metabolic syndrome and gallstone disease. World J Gastroenterol 2012;18:4215–20. 10.3748/wjg.v18.i31.4215
    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;65:146–81. 10.1016/j.jhep.2016.03.005
    1. Tazuma S, Unno M, Igarashi Y, et al. . Evidence-based clinical practice guidelines for cholelithiasis 2016. J Gastroenterol 2017;52:276–300. 10.1007/s00535-016-1289-7
    1. Williams E, Beckingham I, El Sayed G, et al. . Updated guideline on the management of common bile duct stones (CBDS). Gut 2017;66:765–82. 10.1136/gutjnl-2016-312317
    1. Internal Clinical Guidelines T National Institute for health and care excellence: clinical guidelines. gallstone disease: diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis. 2014 London: National Institute for Health and Care Excellence (UK) Copyright (c) National Clinical Guideline Centre, 2014.
    1. Baucom RB, Feurer ID, Shelton JS, et al. . Surgeons, ERCP, and laparoscopic common bile duct exploration: do we need a standard approach for common bile duct stones? Surg Endosc 2016;30:414–23. 10.1007/s00464-015-4273-z
    1. Dasari BV, Tan CJ, Gurusamy KS, et al. . Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev 2013;12.
    1. Williams EJ, Green J, Beckingham I, et al. . Guidelines on the management of common bile duct stones (CBDS). Gut 2008;57:1004–21. 10.1136/gut.2007.121657
    1. Alexakis N, Connor S. Meta-analysis of one- vs. two-stage laparoscopic/endoscopic management of common bile duct stones. HPB 2012;14:254–9. 10.1111/j.1477-2574.2012.00439.x
    1. Reinders JSK, Gouma DJ, Ubbink DT, et al. . Transcystic or transductal stone extraction during single-stage treatment of choledochocystolithiasis: a systematic review. World J Surg 2014;38:2403–11. 10.1007/s00268-014-2537-8
    1. Prasson P, Bai X, Zhang Q, et al. . One-stage laproendoscopic procedure versus two-stage procedure in the management for gallstone disease and biliary duct calculi: a systemic review and meta-analysis. Surg Endosc 2016;30:3582–90. 10.1007/s00464-015-4657-0
    1. Yin Z, Xu K, Sun J, et al. . Is the end of the T-tube drainage era in laparoscopic choledochotomy for common bile duct stones is coming? A systematic review and meta-analysis. Ann Surg 2013;257:54–66. 10.1097/SLA.0b013e318268314b
    1. Lu J, Cheng Y, Xiong X-Z, et al. . Two-stage vs single-stage management for concomitant gallstones and common bile duct stones. World J Gastroenterol 2012;18:3156–66. 10.3748/wjg.v18.i24.3156
    1. Zhu JG, Han W, Guo W, et al. . Learning curve and outcome of laparoscopic transcystic common bile duct exploration for choledocholithiasis. Br J Surg 2015;102:1691–7. 10.1002/bjs.9922
    1. Toouli J. Sphincter of Oddi: function, dysfunction, and its management. J Gastroenterol Hepatol 2009;24:S57–62. 10.1111/j.1440-1746.2009.06072.x
    1. Pan L, Chen M, Ji L, et al. . The safety and efficacy of laparoscopic common bile duct exploration combined with cholecystectomy for the management of Cholecysto-choledocholithiasis: an up-to-date meta-analysis. Ann Surg 2018;268:247–53. 10.1097/SLA.0000000000002731
    1. Hanif F, Ahmed Z, Samie MA, et al. . Laparoscopic transcystic bile duct exploration: the treatment of first choice for common bile duct stones. Surg Endosc 2010;24:1552–6. 10.1007/s00464-009-0809-4
    1. Zhu J-gao, Han W, Zhang Z-tao, et al. . Short-term outcomes of laparoscopic transcystic common bile duct exploration with discharge less than 24 hours. J Laparoendosc Adv Surg Tech A 2014;24:302–5. 10.1089/lap.2013.0537
    1. Lyass S, Phillips EH. Laparoscopic transcystic duct common bile duct exploration. Surg Endosc 2006;20:S441–5. 10.1007/s00464-006-0029-0
    1. Rojas-Ortega S, Arizpe-Bravo D, Marín López ER, et al. . Transcystic common bile duct exploration in the management of patients with choledocholithiasis. J Gastrointest Surg 2003;7:492–6. 10.1016/S1091-255X(03)00026-X
    1. Paganini AM, Guerrieri M, Sarnari J, et al. . Thirteen years' experience with laparoscopic transcystic common bile duct exploration for stones. Effectiveness and long-term results. Surg Endosc 2007;21:34–40. 10.1007/s00464-005-0286-3
    1. Chen X-M, Zhang Y, Cai H-H, et al. . Transcystic approach with micro-incision of the cystic duct and its confluence part in laparoscopic common bile duct exploration. J Laparoendosc Adv Surg Tech A 2013;23:977–81. 10.1089/lap.2013.0309
    1. Raestrup H, Kanehira E, Weiss U, et al. . Laparoscopic treatment of common bile duct stones. Phantom experiments using electrohydraulic and pulsed dye laser lithotripsy. Endosc Surg Allied Technol 1993;1:137–43.

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