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

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ClinicalTrials.gov Identifier: NCT02330601
Recruitment Status : Active, not recruiting
First Posted : January 5, 2015
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endoscopic Papillary Large Balloon Dilation Procedure: endoscopic papillary large balloon dilation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : August 2014
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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
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
 Procedure: endoscopic 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
Other Name: EPLBD


Outcome Measures
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Primary Outcome Measures :
  1. Recurrent rate of CBDS within two years after ERCP [ Time Frame: up to 2 years ]
    Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery


Secondary Outcome Measures :
  1. recurrent time [ Time Frame: up to 2 years ]
  2. success rate of stone extraction [ Time Frame: up to 2 years ]
  3. success rate of stone extraction in the initial attempt [ Time Frame: up to 2 years ]
  4. performance time of ERCP [ Time Frame: up to 2 years ]
  5. rate of mechanical lithotripsy [ Time Frame: up to 2 years ]
  6. post-ERCP complication [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330601


Locations
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China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
Air Force Military Medical University, China
Investigators
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Principal Investigator: Yanglin Pan, MD Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT02330601    
Other Study ID Numbers: 20140424-6
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical