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Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct

NCT02330601 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-05-31

No results posted yet for this study

Summary

The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up to 60% of patients had stone recurrence within two years after stone retrieval by ERCP. Although EPLBD is useful for for extraction of large CBDS with less operation time and mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term recurrence of CBD stones in patients with previous ES. It is a retrospective study with a small sample size (n=94).

Here a prospective, randomized controlled study including two tertiary centers was designed. The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in patients with recurrent CBDS.

Conditions

  • Endoscopic Papillary Large Balloon Dilation

Interventions

PROCEDURE

endoscopic papillary large balloon dilation

For the patients in EPLBD group, a CRE balloon (diameter 10, 11, 12, 13.5, 15 mm; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast. When the waist disappeared, the balloon was kept inflated for 120s. The stones were then retrieved by a basket or a retrieval balloon.Mechanical lithotripsy was used if necessary

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Yanglin Pan, MD · Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2021-06-10
Completion
2021-06-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330601 on ClinicalTrials.gov