Endoscopic Papillary Large Balloon Dilation
Conditions
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.
Interventions
PROCEDUREendoscopic 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
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| success rate of stone extraction | up to 2 years |
| success rate of stone extraction in the initial attempt | up to 2 years |
| recurrent time | up to 2 years |
| rate of mechanical lithotripsy | up to 2 years |
| post-ERCP complication | up to 2 years |
| performance time of ERCP | up to 2 years |
Countries
China
Outcome results
None listed