NCT02330601

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2021-06-10
• Completion: 2021-06-11
• First posted: 2015-01-05
• Last updated: 2023-05-31

Locations

2 sites across 1 country: China