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NCT06041113 Clinical Trial

Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones

Choledocholithiasis Clinical Trial

Official title:
Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones：a Long-term Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06041113
Other study ID # KY20232281-C-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date July 2024

Study information
Verified date September 2023
Source Air Force Military Medical University, China
Contact Yanglin Pan, MD
Phone 86-29-84771536
Email yanglinpan@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 104
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Xijing Hospital of Digestive Diseases Xi'an Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & 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, Th — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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