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

Active, not recruiting

• Conditions: Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Gallstones
• Interventions: Other: Whether ERCP or EST is carried out

• Registration Number: NCT05592795
• Lead Sponsor: Qi-Yong Li

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation	Whether ERCP or EST is carried out	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.
Patients with choledocholithiasis	Whether ERCP or EST is carried out	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.

Primary Outcome Measures

Name	Time	Method
Successfully collect all bile samples required	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.

Trial Locations

Locations (3)

Shulan (Hangzhou) Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Quzhou People's Hospital; 🇨🇳 Quzhou, Zhejiang, China

Shulan (Quzhou) Hospital; 🇨🇳 Quzhou, Zhejiang, China