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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Endoscopic Papillary Large Balloon Dilation

Treatments: Procedure: endoscopic papillary large balloon dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02330601

20140424-6

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

control group

No Intervention group

Description:

The papilla orifice could be enlarged by asphincterotomeif necessary. The stones were retrieved by a basket or a retrieval balloon

EPLBD group

Other group

Description:

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

Treatment:

Procedure: endoscopic papillary large balloon dilation