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

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.

SUBMITTER: Zhu JG

PROVIDER: S-EPMC6887007 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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

Zhu Jie-Gao JG Wu Shanshan S Feng Qiushi Q Li Fei F Han Wei W Xiu Dianrong D Tan Haidong H Fu Jianzhu J Li Xun X Shang Dong D Liu Houbao H Li Binglu B Yang Li L Kong Yuanyuan Y Zhan Siyan S Guo Wei W Zhang Zhong-Tao ZT

BMJ open 20191124 11

<h4>Introduction</h4>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 treatment ...[more]

PMID: 31767583

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Project description:IntroductionSevere hyperbilirubinaemia in newborns can be easily complicated by acute bilirubin encephalopathy or even kernicterus, which could lead to neurological sequelae or death. However, there is no systematic study of the management of severe hyperbilirubinaemia in China. The Neonatal Severe Hyperbilirubinemia Online Registry study aims to investigate the management of jaundice before admission, risk factors and outcomes of severe hyperbilirubinaemia in a real-world setting in China.Methods and analysisThis is a prospective, multicentre, open, observational cohort study. From May 2020 to April 2023, more than 2000 patients with neonatal severe hyperbilirubinaemia from 13 tertiary hospitals in Jiangsu Province will join the study. Demographic data and treatment information will be collected from their clinical data. Management measures for jaundice before admission will be collected by the WeChat applet (called 'Follow-up of jaundice') after being provided by the patient's guardian using a mobile phone. Follow-up data will include cranial MRI examination results, brainstem auditory-evoked potential or automatic auditory brainstem response, physical examination results and Griffiths Development Scales-Chinese at the corrected ages of 3-6 months and 1 and 2 years. Results and conclusions will be recorded using 'Follow-up of jaundice.' In-hospital outcomes, including severity of hyperbilirubinaemia (severe, extreme, hazardous), acute bilirubin encephalopathy (mild, moderate, severe) and survival status (death or survival), will be collected at discharge. Follow-up outcomes will include loss to follow-up, survival status and kernicterus (yes or no) at 2 years. The research will enhance our comprehensive knowledge of jaundice management before admission, risk factors and outcomes of severe hyperbilirubinaemia in China, which will ultimately help to reduce the incidence of neonatal severe hyperbilirubinaemia.Ethics and disseminationOur protocol has been approved by the Medical Ethics Committee of Nanjing Maternity and Child Health Care Hospital. We will present our findings at national conferences and peer-reviewed paediatrics journals.Trial registration numberNCT04251286.

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Dataset Information

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

Publications

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

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