Endoscopic Papillary Large Balloon DilationNCT02330601
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
A study testing endoscopic papillary large balloon dilation in people with Endoscopic Papillary Large Balloon Dilation, run by Air Force Military Medical University, China at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Papillary Large Balloon Dilation
- What is being tested?
- endoscopic papillary large balloon dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2014to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Patients with recurrent CBDS after ERCP
Who cannot join
- 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
Show all 9Show fewer
- With expected life span less than 24 months
- Pregnant women
- Refusal or unable to give written informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
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.
- Being tested
- endoscopic papillary large balloon dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic papillary large balloon dilationProcedure or surgery
Also called EPLBD
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: endoscopic papillary large balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 years
Secondary outcomes (6)
recurrent time
Measured: up to 2 years
success rate of stone extraction
Measured: up to 2 years
success rate of stone extraction in the initial attempt
Measured: up to 2 years
performance time of ERCP
Measured: up to 2 years
rate of mechanical lithotripsy
Measured: up to 2 years
post-ERCP complication
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study start1 Jun 2014
- Primary completion10 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Papillary Large Balloon DilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, MD, Principal investigator, Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330601
- Sponsor's protocol ID
- 20140424-6
- Status last verified
- May 2023
- First submitted
- 31 Dec 2014
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23581623Stefanidis 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.
PubMed 21045816Wang 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.
PubMed 35191430
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
- ClinicalTrials.gov ID
- NCT02330601
- Acronym / sponsor ID
- 20140424-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: endoscopic papillary large balloon dilationa 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- Patients with recurrent CBDS after ERCP
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic papillary large balloon dilationAlso: EPLBDFor 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 | Procedure or surgery | EPLBD group |
Primary outcome
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
6 secondary outcomes
recurrent time
Time frame: up to 2 years
success rate of stone extraction
Time frame: up to 2 years
success rate of stone extraction in the initial attempt
Time frame: up to 2 years
performance time of ERCP
Time frame: up to 2 years
rate of mechanical lithotripsy
Time frame: up to 2 years
post-ERCP complication
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 23581623Yoon 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 publication: PubMed 21045816Stefanidis 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.
- Derived from this study: PubMed 35191430Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanglin Pan, MD principal investigator
Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic papillary large balloon dilation in people with Endoscopic Papillary Large Balloon Dilation, run by Air Force Military Medical University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent rate of CBDS within two years after ERCP (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.