- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330601
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Shaanxi
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Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shaanxi, China, 710032
- Xijing Hospital of Digestive Diseases
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
The papilla orifice could be enlarged by asphincterotomeif necessary.
The stones were retrieved by a basket or a retrieval balloon
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|
Other: 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
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrent rate of CBDS within two years after ERCP
Time Frame: up to 2 years
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Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrent time
Time Frame: up to 2 years
|
up to 2 years
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success rate of stone extraction
Time Frame: up to 2 years
|
up to 2 years
|
success rate of stone extraction in the initial attempt
Time Frame: up to 2 years
|
up to 2 years
|
performance time of ERCP
Time Frame: up to 2 years
|
up to 2 years
|
rate of mechanical lithotripsy
Time Frame: up to 2 years
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up to 2 years
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post-ERCP complication
Time Frame: up to 2 years
|
up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yanglin Pan, MD, Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140424-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endoscopic Papillary Large Balloon Dilation
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute...CompletedClear Cell Renal Cell Carcinoma | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Juvenile Myelomonocytic Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent... and other conditionsUnited States, Germany, Italy
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute...CompletedClear Cell Renal Cell Carcinoma | Recurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent... and other conditionsUnited States, Germany
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University of Southern CaliforniaRecruiting
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National Taiwan University HospitalUnknown
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Second Affiliated Hospital, School of Medicine,...Not yet recruiting
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Samuel H MardiniWithdrawn