Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology

Qi-Yong Li

Status: Active, not recruiting

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Gallstones; Choledocholithiasis

Treatments: Other: Whether ERCP or EST is carried out

Study type: Observational

Funder types: Other

Identifiers

NCT05592795

shulan(hangzhou)1

Details and patient eligibility

About

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.

Full description

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

1. To construct the framework of biliary microecology in normal people, and define the structure and metabolite characteristics of biliary flora;
2. 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
3. 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1.Patients with Gallbladder polyp or gallbladder adenomyosis:

Inclusion Criteria:

1. The patient received laparoscopic cholecystectomy in our hospital from September 1, 2022 to September 1, 2023;
2. Age>18 years old;
3. Postoperative pathology was gallbladder polyp or gallbladder adenomyosis.

Exclusion Criteria:

1. Preoperative biliary surgery history or intraoperative biliary injuried;
2. Other complications were found.

2.Patients with choledocholithiasis:

Inclusion Criteria:

1. The patients were treated in our center from September 1, 2022 to September 1, 2023;
2. Age>18 years old;
3. Patients with choledocholithiasis received ERCP and EST treatment for the first time, but did not receive treatment in other hospitals;
4. The nasobiliary duct is to be retained to drain bile.

Exclusion Criteria:

1. Acute cholangitis;
2. There are serious complications.

3.Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:

Inclusion Criteria:

1. The patients received ERCP treatment in our center from September 1, 2022 to September 1, 2023;
2. Age>18 years old;
3. He has had ERCP and EST operations in the past, and the duodenal papilla was cut during the operation;

Exclusion Criteria:

1. Acute cholangitis;
2. Serious complications

Trial design

75 participants in 3 patient groups

Patients with Gallbladder polyp or gallbladder adenomyosis

Description:

Patients with Gallbladder polyp or gallbladder adenomyosis In view of the difficulty in obtaining bile from normal people, our research team plans to select bile samples from patients undergoing laparoscopic cholecystectomy and patients with pathological diagnosis of gallbladder polyps or gallbladder adenomyosis as physiological bile of normal people.

Patients with choledocholithiasis

Description:

Patients with choledocholithiasis The research group plans to select bile samples from patients with first episode choledocholithiasis, patients receiving ERCP treatment for the first time, and patients undergoing duodenal papillary incision during EST operation to study the biliary flora of patients with choledocholithiasis. Compared with the normal group, analyze whether there are differences, similarities and uniqueness between the groups, dynamically track changes in the structure of biliary flora before and after treatment, and whether there is specific flora related to the type of disease, and compared with the existing biliary microbiome database, to study whether there are new bacterial species.

Treatment:

Other: Whether ERCP or EST is carried out

Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation

Description:

Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation Bile from patients who had undergone ERCP and EST duodenal papillary incision was collected, and the long-term impact of duodenal papillary incision on biliary microecology was discussed by comparing with that of normal patients.

Treatment:

Other: Whether ERCP or EST is carried out