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

Study Overview
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Brief Summary
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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
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Endoscopic Papillary Large Balloon Dilation

Intervention / Treatment
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* Procedure: endoscopic papillary large balloon dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Patients with recurrent CBDS after ERCP Exclusion Criteria: Benign or malignant CBD stricture Recurrent stone within 3 months after ERCP Previous endoscopic papillary large balloon dilation (EPLBD) Prior surgery of Bismuth II and Roux-en-Y Septic shock Coagulopathy (INR>1.3), platelet<50000 or using anti-coagulation drugs With expected life span less than 24 months Pregnant women Refusal or unable to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>The papilla orifice could be enlarged by asphincterotomeif necessary. The stones were retrieved by a basket or a retrieval balloon | |
| Other: EPLBD group<br>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 | Procedure: endoscopic papillary large balloon dilation<br>* 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<br>* Other names: EPLBD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent rate of CBDS within two years after ERCP | Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent time |  | up to 2 years | 
| success rate of stone extraction |  | up to 2 years | 
| success rate of stone extraction in the initial attempt |  | up to 2 years | 
| performance time of ERCP |  | up to 2 years | 
| rate of mechanical lithotripsy |  | up to 2 years | 
| post-ERCP complication |  | up to 2 years |