An observational study in Cholangiopancreatography, Endoscopic Retrograde, Choledocholithiasis and Gallstones, sponsored by Qi-Yong Li. Status unknown at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Qi-Yong Li · Observational
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.
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
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 75 is below the median of 200 across 31 observational studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →This is the only study on the registry with Qi-Yong Li as lead sponsor.
Counted across the registry records on this site, refreshed daily.
1.Patients with Gallbladder polyp or gallbladder adenomyosis:
Inclusion Criteria:
Exclusion Criteria:
2.Patients with choledocholithiasis:
Inclusion Criteria:
Exclusion Criteria:
3.Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:
Inclusion Criteria:
Exclusion Criteria:
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 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 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.
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.
Time frame: 1 week
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Jun 2023, 9 months after the start.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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