Cholangiopancreatography, Endoscopic RetrogradeNCT05592795
Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Choledocholithiasis, run by Qi-Yong Li at 3 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Choledocholithiasis, Gallstones
- What is being tested?
- Whether ERCP or EST is carried out
- How many people
- 75 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2022to 1 Sep 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
- 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;
Show all 10Show fewer
- The nasobiliary duct is to be retained to drain bile.
- 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;
Who cannot join
- Preoperative biliary surgery history or intraoperative biliary injuried;
- Other complications were found.
- 2.Patients with choledocholithiasis:
- Acute cholangitis;
- There are serious complications.
- 3.Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:
- Acute cholangitis;
- Serious complications
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310000
Quzhou People's Hospital
Quzhou, Zhejiang
Shulan (Quzhou) Hospital
Quzhou, Zhejiang
About this study
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.
Read the 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
- To construct the framework of biliary microecology in normal people, and define the structure and metabolite characteristics of biliary flora;
- 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
- 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.
- Being tested
- Whether ERCP or EST is carried out
- Medical subject headings
- Choledocholithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whether ERCP or EST is carried outOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Whether ERCP or EST is carried out |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Qi-Yong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi-Yong Li, Shulan (Hangzhou) Hospital
- Investigators
- Qi-Yong Li, doctor, Study director, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592795
- Sponsor's protocol ID
- shulan(hangzhou)1
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26348073Yu 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.
PubMed 28676707Mima 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.
PubMed 28527946Molinero 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.
PubMed 31272480Shen 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.
PubMed 26625708Ye 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.
PubMed 26930491Swidsinski 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.
PubMed 7875489Kawai 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.
PubMed 11808974Kose 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.
PubMed 30046045Law R, Baron TH. ERCP. Gastrointest Endosc. 2013 Sep;78(3):428-33. doi: 10.1016/j.gie.2013.06.018. No abstract available.
PubMed 23948191Li 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.
PubMed 22736016Li 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.
PubMed 24008462Williams 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.
PubMed 18321943Saito 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.
PubMed 34025069Kageoka 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.
PubMed 19691764
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
- ClinicalTrials.gov ID
- NCT05592795
- Acronym / sponsor ID
- shulan(hangzhou)1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Qi-Yong LiUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To construct the framework of biliary microecology in normal people, and define the structure and metabolite characteristics of biliary flora;
- 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
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Whether ERCP or EST is carried outPatients 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. |
| Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation | – | Other: Whether ERCP or EST is carried outPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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.
- The patients were treated in our center from September 1, 2022 to September 1, 2023;
- Age>18 years old;
Key exclusion criteria (8 listed)
- Preoperative biliary surgery history or intraoperative biliary injuried;
- Other complications were found.
- Acute cholangitis;
- There are serious complications.
- 3.Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whether ERCP or EST is carried outThis 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. | Other | Patients with choledocholithiasis, Patients with previous ERCP and/or EST operations and duodenal papilla incision during operation |
Primary outcome
Successfully collect all bile samples required
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 26348073Konturek 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.
- Background: PubMed 28676707Yu 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.
- Background: PubMed 28527946Mima 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.
- Background: PubMed 31272480Molinero 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.
- Background: PubMed 26625708Shen 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.
- Background: PubMed 26930491Ye 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.
- Background: PubMed 7875489Swidsinski 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.
- Background: PubMed 11808974Kawai 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.
- Background: PubMed 30046045Kose 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.
- Background: PubMed 23948191Law R, Baron TH. ERCP. Gastrointest Endosc. 2013 Sep;78(3):428-33. doi: 10.1016/j.gie.2013.06.018. No abstract available.
- Background: PubMed 22736016Li 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.
- Background: PubMed 24008462Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi-Yong Li, doctor study director
Shulan (Hangzhou) Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Choledocholithiasis, run by Qi-Yong Li at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successfully collect all bile samples required (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592795, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.