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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Calculi
• Choledocholithiasis

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