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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05592795
• Other study ID #: shulan(hangzhou)1
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2023
• Source: Shulan (Hangzhou) Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Choledocholithiasis
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
China	Shulan (Hangzhou) Hospital	Hangzhou	Zhejiang
China	Quzhou People's Hospital	Quzhou	Zhejiang
China	Shulan (Quzhou) Hospital	Quzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Qi-Yong Li

Country where clinical trial is conducted

China, 

References & Publications (15)

Kageoka M, Watanabe F, Maruyama Y, Nagata K, Ohata A, Noda Y, Miwa I, Ikeya K. Long-term prognosis of patients after endoscopic sphincterotomy for choledocholithiasis. Dig Endosc. 2009 Jul;21(3):170-5. doi: 10.1111/j.1443-1661.2009.00880.x. — View Citation

Kawai M, Iwahashi M, Uchiyama K, Ochiai M, Tanimura H, Yamaue H. Gram-positive cocci are associated with the formation of completely pure cholesterol stones. Am J Gastroenterol. 2002 Jan;97(1):83-8. doi: 10.1111/j.1572-0241.2002.05425.x. — View Citation

Konturek PC, Haziri D, Brzozowski T, Hess T, Heyman S, Kwiecien S, Konturek SJ, Koziel J. Emerging role of fecal microbiota therapy in the treatment of gastrointestinal and extra-gastrointestinal diseases. J Physiol Pharmacol. 2015 Aug;66(4):483-91. — View Citation

Kose SH, Grice K, Orsi WD, Ballal M, Coolen MJL. Metagenomics of pigmented and cholesterol gallstones: the putative role of bacteria. Sci Rep. 2018 Jul 25;8(1):11218. doi: 10.1038/s41598-018-29571-8. Erratum In: Sci Rep. 2020 Mar 4;10(1):4347. — View Citation

Law R, Baron TH. ERCP. Gastrointest Endosc. 2013 Sep;78(3):428-33. doi: 10.1016/j.gie.2013.06.018. No abstract available. — View Citation

Li QY, Chen KJ, Jin J, Zheng SS. Guide wire-assisted technique to access the bile duct with biopsy forceps for repositioning and removal of metal stents. Endoscopy. 2013;45 Suppl 2 UCTN:E273-4. doi: 10.1055/s-0033-1344591. Epub 2013 Sep 5. No abstract available. — View Citation

Li QY, Pan L, Ling Q, He JD, Zhang LX, Zheng SS. Single-operator wire-guided cannulation technique enables easier cannulation of endoscopic retrograde cholangiopancreatography. Dig Dis Sci. 2012 Dec;57(12):3293-8. doi: 10.1007/s10620-012-2274-5. Epub 2012 Jun 27. — View Citation

Mima K, Nakagawa S, Sawayama H, Ishimoto T, Imai K, Iwatsuki M, Hashimoto D, Baba Y, Yamashita YI, Yoshida N, Chikamoto A, Baba H. The microbiome and hepatobiliary-pancreatic cancers. Cancer Lett. 2017 Aug 28;402:9-15. doi: 10.1016/j.canlet.2017.05.001. Epub 2017 May 17. — View Citation

Molinero N, Ruiz L, Milani C, Gutierrez-Diaz I, Sanchez B, Mangifesta M, Segura J, Cambero I, Campelo AB, Garcia-Bernardo CM, Cabrera A, Rodriguez JI, Gonzalez S, Rodriguez JM, Ventura M, Delgado S, Margolles A. The human gallbladder microbiome is related to the physiological state and the biliary metabolic profile. Microbiome. 2019 Jul 4;7(1):100. doi: 10.1186/s40168-019-0712-8. — View Citation

Saito H, Kadono Y, Shono T, Kamikawa K, Urata A, Nasu J, Imamura H, Matsushita I, Tada S. Remaining issues of recommended management in current guidelines for asymptomatic common bile duct stones. World J Gastroenterol. 2021 May 14;27(18):2131-2140. doi: 10.3748/wjg.v27.i18.2131. — View Citation

Shen H, Ye F, Xie L, Yang J, Li Z, Xu P, Meng F, Li L, Chen Y, Bo X, Ni M, Zhang X. Metagenomic sequencing of bile from gallstone patients to identify different microbial community patterns and novel biliary bacteria. Sci Rep. 2015 Dec 2;5:17450. doi: 10.1038/srep17450. — View Citation

Swidsinski A, Ludwig W, Pahlig H, Priem F. Molecular genetic evidence of bacterial colonization of cholesterol gallstones. Gastroenterology. 1995 Mar;108(3):860-4. doi: 10.1016/0016-5085(95)90461-1. — View Citation

Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M; British Society of Gastroenterology. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008 Jul;57(7):1004-21. doi: 10.1136/gut.2007.121657. Epub 2008 Mar 5. — View Citation

Ye F, Shen H, Li Z, Meng F, Li L, Yang J, Chen Y, Bo X, Zhang X, Ni M. Influence of the Biliary System on Biliary Bacteria Revealed by Bacterial Communities of the Human Biliary and Upper Digestive Tracts. PLoS One. 2016 Mar 1;11(3):e0150519. doi: 10.1371/journal.pone.0150519. eCollection 2016. — View Citation

Yu LX, Schwabe RF. The gut microbiome and liver cancer: mechanisms and clinical translation. Nat Rev Gastroenterol Hepatol. 2017 Sep;14(9):527-539. doi: 10.1038/nrgastro.2017.72. Epub 2017 Jul 5. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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