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RecruitingNCT06041113Updated Sep 18, 2023

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

An observational study in Intrahepatic Bile Duct Stone and Choledocholithiasis, sponsored by Air Force Military Medical University, China. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Air Force Military Medical University, China · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
104
Sex
All
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Study 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.

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Conditions studied

  • Intrahepatic Bile Duct Stone
  • Choledocholithiasis

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In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's planned enrollment of 104 is below the median of 200 across 31 observational studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Browse Air Force Military Medical University, China studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
104 participants (estimated)
Patient registry
No
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What researchers measure

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.

    Time frame: up to 2 years

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 30979521 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2023; primary completion for Jul 2024, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2023
First posted
Sep 18, 2023
StartEst.
Sep 2023
Primary completionEst.
Jul 2024
CompletionEst.
Jul 2024
Last update
Sep 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06041113
Lead sponsor
Air Force Military Medical University, China
Responsible party
Yanglin Pan (Professor, Air Force Military Medical University, China) — Principal investigator
First posted
Sep 18, 2023
Start date
Sep 2023 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Sep 18, 2023

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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