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

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ClinicalTrials.gov Identifier: NCT06041113
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

Study Description
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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.

Condition or disease
Intrahepatic Bile Duct Stone Choledocholithiasis

Study Design
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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. the recurrence rate of EBD stones [ Time Frame: up to 2 years ]
    Stone recurrence was defined as new EBD stone formation beyond 3 months after complete initial clearance.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with intrahepatic and extrahepatic bile duct stones who underwent ERCP choledocholithotomy were eligible for our study
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041113


Contacts
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Contact: Yanglin Pan, MD 86-29-84771536 yanglinpan@hotmail.com

Locations
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China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yanglin Pan    86-29-84771536    yanglinpan@hotmail.com   
Sponsors and Collaborators
Air Force Military Medical University, China
More Information
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Publications of Results:

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Responsible Party: Yanglin Pan, Professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT06041113    
Other Study ID Numbers: KY20232281-C-1
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Choledocholithiasis
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases
 Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis