CREST 胆石症研究方案（中国胆囊-胆总管结石病治疗观察性研究）：一项前瞻性、多中心、观察性、开放式队列研究。
Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study.
机构信息
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Beijing Key Laboratory of Cancer Invasion and Metastasis Research, Beijing, China.
出版信息
BMJ Open. 2019 Nov 24;9(11):e030293. doi: 10.1136/bmjopen-2019-030293.
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.
简介
对于胆总管结石的最佳治疗方法仍然存在争议。胆总管结石通常采用内镜下括约肌切开术（EST）、腹腔镜胆总管探查术（LCBDE）或腹腔镜经胆囊管胆总管探查术（LTCBDE）治疗。关于这些方法在中国治疗胆囊合并胆总管结石患者的临床结局的数据有限。也缺乏这些治疗方法相关经济负担的分析。中国胆囊-胆总管结石治疗登记研究（CREST Choles）旨在真实环境中解决这些问题。
方法和分析
CREST Choles 是一项前瞻性、多中心、观察性、开放性队列研究。2013 年 1 月 1 日至 2018 年 12 月 1 日期间，共有 2700 例在参与中心接受三种治疗方法之一（EST+腹腔镜胆囊切除术（LC）、LCBDE+LC 和 LTCBDE+LC）的患者纳入本研究。纳入的患者均为有胆囊结石和确诊胆总管结石的患者。收集人口统计学、病史、手术细节、影像学特征和随访数据。在研究入组后至少随访 6 个月，每年随访至 2020 年 12 月。主要结局是术后 3 年内不良结局的发生率。将进行经济分析（如增量成本效益比）以比较不同治疗方法的费用。
伦理和传播
所有参与中心均获得伦理批准。本注册研究首次尝试全面评估中国胆囊合并胆总管结石的治疗费用。预计结果将于 2020 年公布，将有助于此类病例的临床决策。
试验注册编号
NCT02554097。
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