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

Sponsor
Qi-Yong Li (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05592795
Collaborator
(none)
75
3
12
25
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Whether ERCP or EST is carried out

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
75 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with Gallbladder polyp or gallbladder adenomyosis

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

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.

Other: Whether ERCP or EST is carried out
This project systematically studies the physiological characteristics of biliary microecology in normal people, and explores the impact of ERCP and EST duodenal papillary incision on biliary microecology.

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

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.

Other: Whether ERCP or EST is carried out
This project systematically studies the physiological characteristics of biliary microecology in normal people, and explores the impact of ERCP and EST duodenal papillary incision on biliary microecology.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shulan (Hangzhou) Hospital Hangzhou Zhejiang China 310000
2 Quzhou People's Hospital Quzhou Zhejiang China
3 Shulan (Quzhou) Hospital Quzhou Zhejiang China

Sponsors and Collaborators

  • Qi-Yong Li

Investigators

  • Study Director: Qi-Yong Li, doctor, Shulan (Hangzhou) Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qi-Yong Li, professor, Shulan (Hangzhou) Hospital
ClinicalTrials.gov Identifier:
NCT05592795
Other Study ID Numbers:
  • shulan(hangzhou)1
First Posted:
Oct 25, 2022
Last Update Posted:
Oct 25, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2022