CholedocholithiasisNCT05056506
EPLBD With Limited EST vs. EPLBD for Choledocholithiasis
A study testing EPLBD and ELPBD+ESD in people with Choledocholithiasis, run by Jianfeng Yang at 2 sites in China.
Trial summary
Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- EPLBD and ELPBD+ESD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2021to 30 Oct 2023
- 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
- large bile duct stones (≥10 mm)
Who cannot join
- pregnancy
- refusal of written informed consent
- Patients with benign or malignant biliary stricture
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
- Coagulation dysfunction，thrombocytopenia
- prior EST or EPBD
- Patients after gastrointestinal reconstruction
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 31006
Jianfeng Yang, M.D, +86-0571-56006999, yjf-1976@163.com
Yang Wang, M.S, +86-0571-56006996, wy8124@163.com
- Recruiting
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality
Zhou Min, 13564878508
About this study
Official title: A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.
Read the detailed description
ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.
- Conditions
- Choledocholithiasis
- Being tested
- EPLBD, ELPBD+ESD
- Keywords
- Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety, Choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPLBDProcedure or surgery
Endoscopic papillary large balloon dilation for Choledocholithiasis
ELPBD+ESDProcedure or surgery
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic papillary large balloon dilation group | Active comparator | Endoscopic papillary large balloon dilation to extract bile duct stones Receives: Procedure: EPLBD |
| Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group | Experimental | Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones Receives: Procedure: ELPBD+ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of complications
The incidence of complications
Measured: within 1 months after the procedure
Secondary outcomes (4)
The success rate of 1st session treatment
The success rate of 1st session treatment
Measured: within 1 months after the procedure
The rate of mechanical lithotripsy
The rate of mechanical lithotripsy
Measured: within 1 months after the procedure
Total ercp times
Total ercp numbers
Measured: within 1 months after the procedure
Overall successful stone removal rate
Overall successful stone removal rate
Measured: within 1 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Yang
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shanghai Fourth People's Hospital Tongji University
- Responsible party
- Sponsor-investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056506
- Sponsor's protocol ID
- 2021-02-01
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013 Jan 17;13:15. doi: 10.1186/1471-230X-13-15.
PubMed 23324454
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
- ClinicalTrials.gov ID
- NCT05056506
- Acronym / sponsor ID
- 2021-02-01
- Conditions
- Choledocholithiasis
- Keywords
- Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Jianfeng YangUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shanghai Fourth People's Hospital Tongji University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 24 Sep 2021 (actual)
- 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.
Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.
Detailed description
ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic papillary large balloon dilation group | Active comparator | Procedure: EPLBDEndoscopic papillary large balloon dilation to extract bile duct stones |
| Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group | Experimental | Procedure: ELPBD+ESDEndoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- large bile duct stones (≥10 mm)
Key exclusion criteria (8 listed)
- pregnancy
- refusal of written informed consent
- Patients with benign or malignant biliary stricture
- Contraindications to ERCP exist
- Complicated with acute pancreatitis or acute cholangitis
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 |
|---|---|---|
| EPLBDEndoscopic papillary large balloon dilation for Choledocholithiasis | Procedure or surgery | Endoscopic papillary large balloon dilation group |
| ELPBD+ESDEndoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis | Procedure or surgery | Endoscopic papillary Large balloon dilation combined with limited endoscopic sphincterotomy group |
Primary outcome
The incidence of complications
Time frame: within 1 months after the procedure
The incidence of complications
4 secondary outcomes
The success rate of 1st session treatment
Time frame: within 1 months after the procedure
The rate of mechanical lithotripsy
Time frame: within 1 months after the procedure
Total ercp times
Time frame: within 1 months after the procedure
Overall successful stone removal rate
Time frame: within 1 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 23324454Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013 Jan 17;13:15. doi: 10.1186/1471-230X-13-15.
- Individual participant dataSharing planned: No
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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.
Xiaofeng Zhang principal investigator
Zhejiang 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 EPLBD and ELPBD+ESD in people with Choledocholithiasis, run by Jianfeng Yang 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Yang, Doctor (086-13454132186, yjf-1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of complications (time frame: within 1 months after the procedure). 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 NCT05056506, which also lists 1 linked publication.
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 16 Aug 2023.