Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones
1 other identifier
observational
104
1 country
1
Brief Summary
The management of coexisting intrahepatic bile duct (IBD) and extrahepatic bile duct (EBD) stones is complicated and requires a multidisciplinary approach. The long-term clinical outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography (ERCP) EBD stone extraction remain unclear. Investigators conducted a retrospective study of patients with coexisting IBD and EBD to investigate the long-term impact of ERCP on the incidence of recurrent EBD stones and to identify risk factors of recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 5, 2023
CompletedFirst Posted
Study publicly available on registry
September 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedSeptember 18, 2023
September 1, 2023
10 months
September 5, 2023
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the recurrence rate of EBD stones
Stone recurrence was defined as new EBD stone formation beyond 3 months after complete initial clearance.
up to 2 years
Eligibility Criteria
patients with intrahepatic and extrahepatic bile duct stones who underwent ERCP choledocholithotomy were eligible for our study
You may qualify if:
- non-gastrointestinal tract reconstruction patients with coexisting IBD and EBD stones who underwent ERCP between July 2008 and December 2020 at Xijing Hospital in China
You may not qualify if:
- patients with benign or malignant EBD strictures
- sclerosing cholangitis
- suspected choledochal cysts
- liver cirrhosis
- parasitic liver diseases
- long-term biliary drainage with biliary stents or percutaneous tubes
- without a definitive IBD stone or with a diagnosis of liver calcification as determined by imaging review
- medical records or follow-up information was unavailable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
Related Publications (1)
ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
PMID: 30979521RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 18, 2023
Study Start
September 1, 2023
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
September 18, 2023
Record last verified: 2023-09