Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study
机构：[1]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China 首都医科大学附属北京友谊医院[2]Beijing Key Laboratory of Cancer Invasion and Metastasis Research, Beijing, China [3]National Clinical Research Center for Digestive Diseases, Beijing, China 首都医科大学附属北京友谊医院[4]Beijing Institute of Clinical Medicine, Beijing, China [5]Clinical Epidemiology and Evidence-Based Medicine Unit, Beijing Friendship Hospital, Capital Medical University, Beijing, China 首都医科大学附属北京友谊医院[6]Endoscopy Center, Peking University First Hospital, Beijing, China [7]Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China 首都医科大学宣武医院[8]Department of General Surgery, Beijing Luhe Hospital, Capital Medical University, Beijing, China [9]Department of General Surgery, Peking University Third Hospital, Beijing, China [10]Department of General Surgery, China-Japan Friendship Hospital, Beijing, China [11]Department of General Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China 临床科室普外科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[12]Department of General Surgery, The First Hospital of LanZhou University, Lanzhou, China [13]Department of General Surgery, First Affiliated Hospital of Dalian Medical University, Dalian, China 大连医科大学附属第一医院[14]Department of General Surgery, Zhongshan Hospital Affiliated to Fudan University, Shanghai, China [15]Department of General Surgery, Peking Union Medical College Hospital, Beijing, China [16]Department of Health Policy and Management, School of Public Health, Peking University, Beijing, China [17]Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China
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.
基金：
Capital Health Research and Special Development [2016-1-1111]; National Key Technologies RD ProgramNational Key Technology R&D Program [2015BAI13B09]; Beijing Municipal Administration of Hospitals Incubator Program [PX2016001, PX2019004]
第一作者机构：[1]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China [2]Beijing Key Laboratory of Cancer Invasion and Metastasis Research, Beijing, China [3]National Clinical Research Center for Digestive Diseases, Beijing, China [4]Beijing Institute of Clinical Medicine, Beijing, China
通讯作者：
通讯机构：[1]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China [2]Beijing Key Laboratory of Cancer Invasion and Metastasis Research, Beijing, China [3]National Clinical Research Center for Digestive Diseases, Beijing, China [4]Beijing Institute of Clinical Medicine, Beijing, China
推荐引用方式(GB/T 7714)：
Zhu Jie-Gao,Wu Shanshan,Feng Qiushi,et al.Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study[J].BMJ OPEN.2019,9(11):doi:10.1136/bmjopen-2019-030293.
APA：
Zhu, Jie-Gao,Wu, Shanshan,Feng, Qiushi,Li, Fei,Han, Wei...&Zhang, Zhong-Tao.(2019).Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study.BMJ OPEN,9,(11)
MLA：
Zhu, Jie-Gao,et al."Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study".BMJ OPEN 9..11(2019)
