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

NCT05592795 | Unknown

• 1 other identifier: shulan(hangzhou)1
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Choledocholithiasis; Gallstones

Outcome Measures

Primary Outcomes (1)

• Successfully collect all bile samples required

  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.

  1 week

Study Arms (3)

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

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

Interventions

Whether ERCP or EST is carried out OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with Gallbladder polyp or gallbladder adenomyosis 2. Patients with choledocholithiasis 3. Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation

You may qualify if:

• 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.

You may not qualify if:

• Preoperative biliary surgery history or intraoperative biliary injuried;
• Other complications were found.
• Patients with choledocholithiasis:
• 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.
• Acute cholangitis;
• There are serious complications.
• Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:
• 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;
• Acute cholangitis;
• Serious complications

Sponsors & Collaborators

• Qi-Yong Li: lead

Study Sites (3)

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310000, China

Location

Quzhou People's Hospital

Quzhou, Zhejiang, China

Location

Shulan (Quzhou) Hospital

Quzhou, Zhejiang, China

Location

Related Publications (15)

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  PMID: 31272480 BACKGROUND

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  PMID: 23948191 BACKGROUND

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  PMID: 19691764 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

microorganisms in bile

MeSH Terms

Conditions

Choledocholithiasis; Gallstones

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Qi-Yong Li, doctor

  Shulan (Hangzhou) Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)