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

Primary Purpose

Endoscopic Papillary Large Balloon Dilation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic papillary large balloon dilation
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endoscopic Papillary Large Balloon Dilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xijing Hospital of Digestive Diseases
  • The First Affiliated Hospital Of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

control group

EPLBD group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

recurrent time
success rate of stone extraction
success rate of stone extraction in the initial attempt
performance time of ERCP
rate of mechanical lithotripsy
post-ERCP complication

Full Information

First Posted
December 31, 2014
Last Updated
May 28, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02330601
Brief Title
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Papillary Large Balloon Dilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
The papilla orifice could be enlarged by asphincterotomeif necessary. The stones were retrieved by a basket or a retrieval balloon
Arm Title
EPLBD group
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
endoscopic papillary large balloon dilation
Other Intervention Name(s)
EPLBD
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrent rate of CBDS within two years after ERCP
Description
Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
recurrent time
Time Frame
up to 2 years
Title
success rate of stone extraction
Time Frame
up to 2 years
Title
success rate of stone extraction in the initial attempt
Time Frame
up to 2 years
Title
performance time of ERCP
Time Frame
up to 2 years
Title
rate of mechanical lithotripsy
Time Frame
up to 2 years
Title
post-ERCP complication
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD
Organizational Affiliation
Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23581623
Citation
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.
Results Reference
background
PubMed Identifier
21045816
Citation
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.
Results Reference
result
PubMed Identifier
35191430
Citation
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.
Results Reference
derived

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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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