Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Successfully collect all bile samples required
研究概览
简要总结
The objective of this observational study is to explore the structure of biliary flora in normal people, explore the dynamic impact of ERCP and EST on biliary microecology, study the marker flora, metabolites and functional genes related to biliary diseases, explore the occurrence and development mechanism, regulatory pathways and key targets of biliary diseases, and provide new strategies for the prevention and treatment of biliary diseases from the perspective of biliary microecology.
详细描述
Our research group applied the technology of macro genome sequencing to explore the biliary microecology through genomics and metabonomics analysis, describe the biliary microecology map of normal people, and build the biliary microecology framework of normal people; To explore the dynamic impact of ERCP and EST treatment on biliary tract microecology, and to further study the dynamic changes, abundance information and diversity characteristics of biliary tract microecology in patients with duodenal papillary incision and Oddi sphincter dysfunction, so as to find the marker flora and metabolites related to bile duct diseases, as well as the prognostic predictive value of specific flora and clinical diagnosis and treatment plan. This study provides a new direction for exploring the composition of human biliary microecology and the occurrence and development mechanism of biliary diseases and provides a new strategy for the treatment of patients with biliary diseases. It has important scientific significance and clinical value.
This project systematically studies the physiological characteristics of biliary tract microecology in normal people, explores the impact of ERCP and EST duodenal papillary incision on biliary tract microecology, clarifies the integrated genomic and metabolomic maps of biliary tract microorganisms in different states, compares the differences of biliary tract microecology at different key nodes, looks for the marker flora related to ERCP and EST treatment, and analyzes the correlation between the marker flora and clinical characteristics, To explore the role and mechanism of key bacteria in the occurrence and development of biliary diseases, so as to provide theoretical basis and strategies for improving prognosis for clinical treatment.
Purpose of this study
- To construct the framework of biliary microecology in normal people, and define the structure and metabolite characteristics of biliary flora;
- To study the short-term and long-term changes of biliary microecology in patients with ERCP, EST duodenal papillary incision and Oddi sphincter dysfunction, and explore the influence of specific pathogenic bacteria on the occurrence and development of biliary diseases
- To screen the key flora of biliary microecology disorder before and after ERCP and EST treatment, and to explore the role and mechanism of marker flora in the occurrence and development of biliary diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient received laparoscopic cholecystectomy in our hospital from September 1, 2022 to September 1, 2023;
- •Age>18 years old;
- •Postoperative pathology was gallbladder polyp or gallbladder adenomyosis.
排除标准
- •Preoperative biliary surgery history or intraoperative biliary injuried;
- •Other complications were found.
- •2.Patients with choledocholithiasis:
- •Inclusion Criteria:
- •The patients were treated in our center from September 1, 2022 to September 1, 2023;
- •Age>18 years old;
- •Patients with choledocholithiasis received ERCP and EST treatment for the first time, but did not receive treatment in other hospitals;
- •The nasobiliary duct is to be retained to drain bile.
- •Exclusion Criteria:
- •Acute cholangitis;
- •There are serious complications.
- •3.Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:
- •Inclusion Criteria:
- •The patients received ERCP treatment in our center from September 1, 2022 to September 1, 2023;
- •Age>18 years old;
- •He has had ERCP and EST operations in the past, and the duodenal papilla was cut during the operation;
- •Exclusion Criteria:
- •Acute cholangitis;
- •Serious complications
结局指标
主要结局
Successfully collect all bile samples required
时间窗: 1 week
Collect the required bile samples under the required conditions according to the difference of the three groups.Then DNA extraction, Illumina MiSeq sequencing and bioinformatics analysis will be performed on the collected samples.
次要结局
未报告次要终点
研究者
Qi-Yong Li
professor
Shulan (Hangzhou) Hospital