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

Not Applicable

Completed

• Conditions: Endoscopic Papillary Large Balloon Dilation
• Interventions: Procedure: endoscopic papillary large balloon dilation

• Registration Number: NCT02330601
• Lead Sponsor: Air Force Military Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-05
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age 18-80
2. Patients with recurrent CBDS after ERCP

Exclusion Criteria

1. Benign or malignant CBD stricture
2. Recurrent stone within 3 months after ERCP
3. Previous endoscopic papillary large balloon dilation (EPLBD)
4. Prior surgery of Bismuth II and Roux-en-Y
5. Septic shock
6. Coagulopathy (INR>1.3), platelet<50000 or using anti-coagulation drugs
7. With expected life span less than 24 months
8. Pregnant women
9. Refusal or unable to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPLBD group	endoscopic papillary large balloon dilation	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

Primary Outcome Measures

Name	Time	Method
Recurrent rate of CBDS within two years after ERCP	up to 2 years	Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery

Secondary Outcome Measures

Name	Time	Method
recurrent time	up to 2 years
success rate of stone extraction	up to 2 years
performance time of ERCP	up to 2 years
success rate of stone extraction in the initial attempt	up to 2 years
rate of mechanical lithotripsy	up to 2 years
post-ERCP complication	up to 2 years

Trial Locations

Locations (2)

The First Affiliated Hospital Of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China