Common Bile Duct StoneNCT07030829
Laser vs Electrohydraulic Lithotripsy for Difficult CBD Stones
A study testing Laser Lithotripsy and Electrohydraulic Lithotripsy in people with Common Bile Duct Stone, run by Mahidol University at 2 sites in Thailand.
Trial summary
Common bile duct (CBD) stones are a frequent condition that can lead to severe complications if not treated. The standard approach involves endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction using balloons or baskets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stone
- What is being tested?
- Laser Lithotripsy and Electrohydraulic Lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18 years
- Difficult CBD stone
- Large CBD stone (stone > 1.5 cm) or Stone impaction or CBD stones that were not completely removed using conventional techniques.
Who cannot join
- Pregnancy
- Unstable vital signs
- Severe comorbidities
- Uncorrected coagulopathy
- Surgically altered anatomy
- Unable to complete informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10120
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10ึ700
Ronnakorn Kongsakon, MD, +66655979522, ronnagorn@gmail.com
About this study
Official title: Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial
Common bile duct (CBD) stones are a frequent condition that can lead to severe complications if not treated. The standard approach involves endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction using balloons or baskets. However, approximately 10-15% of cases involve "difficult CBD stones" that cannot be removed using conventional methods.
According to the European Society of Gastrointestinal Endoscopy (ESGE), difficult CBD stones are characterized by large size (≥15 mm), impaction, multiple stones, difficult locations (e.g., intrahepatic or cystic ducts), or altered anatomy due to previous surgeries. These cases require advanced techniques such as single-operator cholangioscopy (SOC) using the SpyGlass DS system, which allows direct stone visualization and lithotripsy-assisted fragmentation.
Read more
Two primary lithotripsy methods are available:
Electrohydraulic Lithotripsy (EHL): Uses shock waves from electrical energy to break stones.
Laser Lithotripsy (LL): Uses laser energy to fragment stones through a water-mediated medium.
While both techniques are effective, studies suggest LL has a higher first-attempt stone clearance rate (82-100%) compared to EHL (70.9-75%). However, EHL is more cost-effective and widely available, whereas LL offers greater precision but at a higher cost. Currently, no randomized controlled trial (RCT) directly compares their efficacy, procedural time, complication rates, or operator satisfaction.
This study aims to fill that gap by conducting a randomized trial comparing EHL and LL in the treatment of difficult CBD stones. The primary outcome is the success rate of complete stone clearance in the first session, while secondary outcomes include procedural duration, post-procedural complications, and operator satisfaction.
The findings will provide critical evidence for optimizing endoscopic stone management, improving patient outcomes, and guiding healthcare resource allocation.
Read the detailed description
Common bile duct (CBD) stones are a prevalent condition that can lead to severe complications if left untreated. The standard treatment method involves endoscopic retrograde cholangiopancreatography (ERCP) for stone removal. Conventional techniques include sphincterotomy combined with balloon or basket extraction. However, approximately 10-15% of patients present with "difficult CBD stones," which cannot be effectively removed using standard techniques.
The European Society of Gastrointestinal Endoscopy (ESGE) defines difficult CBD stones as those meeting one or more of the following criteria: stone size ≥15 mm, impacted stones, multiple stones, stones in difficult-to-access locations (e.g., intrahepatic or cystic ducts), barrel-shaped stones, or stones in patients with altered anatomy due to prior surgical interventions (e.g., Roux-en-Y reconstruction). These cases often require specialized techniques to achieve successful stone clearance while minimizing complications.
Intervention and Rationale:
Single-operator cholangioscopy using the SpyGlass system has become a widely adopted approach for managing difficult CBD stones. This technique enables direct visualization of the stone and facilitates lithotripsy, which fragments stones into smaller pieces for easier removal. The two primary lithotripsy techniques available are:
Electrohydraulic Lithotripsy (EHL): Uses shock waves generated by electrical energy transmitted through a probe to fragment stones.
Laser Lithotripsy (LL): Uses laser energy delivered through a water-mediated medium to break stones into smaller pieces.
Both techniques have demonstrated high success rates in stone fragmentation and removal, but debate persists regarding their relative efficacy. Some studies suggest that LL achieves higher first-attempt stone clearance rates (82-100%) compared to EHL (70.9-75%). However, EHL is generally more cost-effective and widely available, whereas LL offers greater precision at a higher procedural cost.
Objective:
This study aims to compare the effectiveness of EHL and LL in the management of difficult CBD stones through a randomized controlled trial (RCT). The primary outcome is the success rate of complete stone clearance in the first session. Secondary outcomes include procedural time, complication rates, and operator satisfaction.
Study Design:
Study Type: Randomized Controlled Trial
Study Population: Patients diagnosed with difficult CBD stones requiring lithotripsy
Intervention Groups:
Group 1: EHL via SpyGlass DS
Group 2: LL via SpyGlass DS
Primary Endpoint: First-session complete stone clearance rate
Secondary Endpoints:
Procedural duration
Post-procedural complications
Operator satisfaction
Significance:
The findings from this study will provide valuable evidence for endoscopists regarding the optimal lithotripsy method for difficult CBD stones, ultimately improving patient outcomes and healthcare resource utilization. By identifying the most effective and efficient technique, this study aims to optimize treatment strategies and enhance clinical decision-making in endoscopic stone management.
- Conditions
- Common Bile Duct Stone
- Being tested
- Laser Lithotripsy, Electrohydraulic Lithotripsy
- Keywords
- Common bile duct stones, CBD stones, Difficult CBD stones, ERCP, Spyglass, Cholangioscopy, Lithrotripsy, Laser lithrotripsy, EHL, Electrohydraulic Lithotripsy
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser LithotripsyDevice
Laser Lithotripsy
Electrohydraulic LithotripsyDevice
Electrohydraulic Lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Laser Lithotripsy | Experimental | Not described Receives: Device: Laser Lithotripsy |
| Electrohydraulic Lithotripsy | Experimental | Not described Receives: Device: Electrohydraulic Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL)
Comparison of the effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL) by examining the success rate of complete stone removal on the first procedure.
Measured: During the procedure
Secondary outcomes (5)
Procedure time
Procedure time of ERCP with spyglass
Measured: Periprocedural (Total procedure time usually 1-2 hours)
Number of catheters used
Number of catheters used
Measured: Periprocedural
Physician satisfaction
Physician satisfaction of EHL vs LL based on questionaire on a scale of 0-5 for ease of use and lithotripsy effect
Measured: Periprocedural
Procedure-related adverse events
Procedure-related adverse events
Measured: up to 2 weeks after the procedure
Length of hospital stay
Length of hospital stay
Measured: through after procedure average 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StoneStudies 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, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Principal investigator, Varayu Prachayakul, Mahidol University
- Investigators
- Varayu Prachayakul, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030829
- Sponsor's protocol ID
- SI 066/2025
- Status last verified
- May 2025
- First submitted
- 26 Feb 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are willing to provide our data to researchers who require it. For example, those who want to do systematic review and meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07030829
- Acronym / sponsor ID
- SI 066/2025
- Conditions
- Common Bile Duct Stone
- Keywords
- Common bile duct stones, CBD stones, Difficult CBD stones, ERCP, Spyglass, Cholangioscopy, Lithrotripsy, Laser lithrotripsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
Common bile duct (CBD) stones are a frequent condition that can lead to severe complications if not treated. The standard approach involves endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction using balloons or baskets. However, approximately 10-15% of cases involve "difficult CBD stones" that cannot be removed using conventional methods.
According to the European Society of Gastrointestinal Endoscopy (ESGE), difficult CBD stones are characterized by large size (≥15 mm), impaction, multiple stones, difficult locations (e.g., intrahepatic or cystic ducts), or altered anatomy due to previous surgeries. These cases require advanced techniques such as single-operator cholangioscopy (SOC) using the SpyGlass DS system, which allows direct stone visualization and lithotripsy-assisted fragmentation.
Two primary lithotripsy methods are available:
Electrohydraulic Lithotripsy (EHL): Uses shock waves from electrical energy to break stones.
Laser Lithotripsy (LL): Uses laser energy to fragment stones through a water-mediated medium.
While both techniques are effective, studies suggest LL has a higher first-attempt stone clearance rate (82-100%) compared to EHL (70.9-75%). However, EHL is more cost-effective and widely available, whereas LL offers greater precision but at a higher cost. Currently, no randomized controlled trial (RCT) directly compares their efficacy, procedural time, complication rates, or operator satisfaction.
This study aims to fill that gap by conducting a randomized trial comparing EHL and LL in the treatment of difficult CBD stones. The primary outcome is the success rate of complete stone clearance in the first session, while secondary outcomes include procedural duration, post-procedural complications, and operator satisfaction.
The findings will provide critical evidence for optimizing endoscopic stone management, improving patient outcomes, and guiding healthcare resource allocation.
Detailed description
Common bile duct (CBD) stones are a prevalent condition that can lead to severe complications if left untreated. The standard treatment method involves endoscopic retrograde cholangiopancreatography (ERCP) for stone removal. Conventional techniques include sphincterotomy combined with balloon or basket extraction. However, approximately 10-15% of patients present with "difficult CBD stones," which cannot be effectively removed using standard techniques.
The European Society of Gastrointestinal Endoscopy (ESGE) defines difficult CBD stones as those meeting one or more of the following criteria: stone size ≥15 mm, impacted stones, multiple stones, stones in difficult-to-access locations (e.g., intrahepatic or cystic ducts), barrel-shaped stones, or stones in patients with altered anatomy due to prior surgical interventions (e.g., Roux-en-Y reconstruction). These cases often require specialized techniques to achieve successful stone clearance while minimizing complications.
Intervention and Rationale:
Single-operator cholangioscopy using the SpyGlass system has become a widely adopted approach for managing difficult CBD stones. This technique enables direct visualization of the stone and facilitates lithotripsy, which fragments stones into smaller pieces for easier removal. The two primary lithotripsy techniques available are:
Electrohydraulic Lithotripsy (EHL): Uses shock waves generated by electrical energy transmitted through a probe to fragment stones.
Laser Lithotripsy (LL): Uses laser energy delivered through a water-mediated medium to break stones into smaller pieces.
Both techniques have demonstrated high success rates in stone fragmentation and removal, but debate persists regarding their relative efficacy. Some studies suggest that LL achieves higher first-attempt stone clearance rates (82-100%) compared to EHL (70.9-75%). However, EHL is generally more cost-effective and widely available, whereas LL offers greater precision at a higher procedural cost.
Objective:
This study aims to compare the effectiveness of EHL and LL in the management of difficult CBD stones through a randomized controlled trial (RCT). The primary outcome is the success rate of complete stone clearance in the first session. Secondary outcomes include procedural time, complication rates, and operator satisfaction.
Study Design:
Study Type: Randomized Controlled Trial
Study Population: Patients diagnosed with difficult CBD stones requiring lithotripsy
Intervention Groups:
Group 1: EHL via SpyGlass DS
Group 2: LL via SpyGlass DS
Primary Endpoint: First-session complete stone clearance rate
Secondary Endpoints:
Procedural duration
Post-procedural complications
Operator satisfaction
Significance:
The findings from this study will provide valuable evidence for endoscopists regarding the optimal lithotripsy method for difficult CBD stones, ultimately improving patient outcomes and healthcare resource utilization. By identifying the most effective and efficient technique, this study aims to optimize treatment strategies and enhance clinical decision-making in endoscopic stone management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Lithotripsy | Experimental | Device: Laser Lithotripsy |
| Electrohydraulic Lithotripsy | Experimental | Device: Electrohydraulic Lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged >18 years
- Difficult CBD stone
- Large CBD stone (stone > 1.5 cm) or Stone impaction or CBD stones that were not completely removed using conventional techniques.
Key exclusion criteria (6 listed)
- Pregnancy
- Unstable vital signs
- Severe comorbidities
- Uncorrected coagulopathy
- Surgically altered anatomy
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 |
|---|---|---|
| Laser LithotripsyLaser Lithotripsy | Device | Laser Lithotripsy |
| Electrohydraulic LithotripsyElectrohydraulic Lithotripsy | Device | Electrohydraulic Lithotripsy |
Primary outcome
Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL)
Time frame: During the procedure
Comparison of the effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL) by examining the success rate of complete stone removal on the first procedure.
5 secondary outcomes
Procedure time
Time frame: Periprocedural (Total procedure time usually 1-2 hours)
Number of catheters used
Time frame: Periprocedural
Physician satisfaction
Time frame: Periprocedural
Procedure-related adverse events
Time frame: up to 2 weeks after the procedure
Length of hospital stay
Time frame: through after procedure average 1-2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Yes. We are willing to provide our data to researchers who require it. For example, those who want to do systematic review and meta-analysis.
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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.
Varayu Prachayakul, MD principal investigator
Mahidol 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 Laser Lithotripsy and Electrohydraulic Lithotripsy in people with Common Bile Duct Stone, run by Mahidol University at 2 sites in Thailand.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronnakorn Kongsakon, MD (+66655979522, ronnagorn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL) (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.