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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | The papilla orifice could be enlarged by asphincterotomeif necessary. The stones were retrieved by a basket or a retrieval balloon | |
| EPLBD group | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic papillary large balloon dilation | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanglin Pan, MD | Xijing Hospital of Digestive Diseases.The Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China | ||
| The First Affiliated Hospital Of Xi'an Jiaotong University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23581623 | Background | Yoon HG, Moon JH, Choi HJ, Kim DC, Kang MS, Lee TH, Cha SW, Cho YD, Park SH, Kim SJ. Endoscopic papillary large balloon dilation for the management of recurrent difficult bile duct stones after previous endoscopic sphincterotomy. Dig Endosc. 2014 Mar;26(2):259-63. doi: 10.1111/den.12102. Epub 2013 Apr 14. | |
| 21045816 | Result |
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|
|
| 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 |
| Xi'an |
| Shaanxi |
| 710061 |
| China |
| Stefanidis G, Viazis N, Pleskow D, Manolakopoulos S, Theocharis L, Christodoulou C, Kotsikoros N, Giannousis J, Sgouros S, Rodias M, Katsikani A, Chuttani R. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol. 2011 Feb;106(2):278-85. doi: 10.1038/ajg.2010.421. Epub 2010 Nov 2. |
| 35191430 | Derived | Wang X, Wang X, Sun H, Ren G, Wang B, Liang S, Zhang L, Kang X, Tao Q, Guo X, Luo H, Pan Y. Endoscopic Papillary Large Balloon Dilation Reduces Further Recurrence in Patients With Recurrent Common Bile Duct Stones: A Randomized Controlled Trial. Am J Gastroenterol. 2022 May 1;117(5):740-747. doi: 10.14309/ajg.0000000000001690. Epub 2022 Feb 16. |