Common Bile Duct StonesNCT00852072
Randomized Trial for Extraction of Difficult Bile Duct Stones
A study testing Single-operator cholangioscopy-guided laser lithotripsy and Balloon Sphincteroplasty in people with Common Bile Duct Stones, run by AdventHealth at 1 site in United States.
Trial summary
Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- Single-operator cholangioscopy-guided laser lithotripsy and Balloon Sphincteroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 Dec 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over
- Common bile duct stones that measure at least 1.2 cm who have failed stone removal using standard techniques at ERCP
Who cannot join
- Patients unable to provide informed consent due to any diminished capacity
- Pregnant patients or age < 18 years or prisoners
- Presence of bleeding disorders
- Patients with altered post-surgical anatomy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones
Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty), mechanical lithotripsy or single-operator cholangioscopy guided laser lithotripsy techniques. There are currently no randomized trials comparing laser lithotripsy and sphincteroplasty techniques for the removal of difficult bile duct stones and the aim of this randomized trial is to determine which technique is superior in the removal of difficult bile duct stones.
Read the detailed description
Stones in the common bile duct (CBD) can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients with small bile duct stones using standard endoscopic techniques. This comprises endoscopic sphincterotomy whereby the duodenal sphincter at the entrance of the bile duct is cut during endoscopic retrograde cholangiopancreatography (ERCP) and subsequent removal of the stone is achieved using standard accessories such as a basket and/or extraction balloon. However, large/difficult bile duct stones (at least 12mm in size), multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories. In such cases, the three most commonly practiced advanced maneuvers for extraction of difficult CBD stones are mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided laser lithotripsy (SOC-LL).
Endoscopic large balloon sphincteroplasty (using CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) is a technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 20mm (depending on size of the distal CBD) after performing an endoscopic sphincterotomy. Following dilation, the stone is removed using a basket and/or extraction balloon. This technique was shown to be effective in clearing the bile duct in 50-60% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.
The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator cholangioscopy system, which allows direct visualization of the bile duct stone. The main advantage of this technique is that the cholangioscope can be inserted into the endoscope and then guided through the bile duct to reach the stone. A probe can then be inserted into the cholangioscope to allow the energy from laser (laser lithotripsy) to be accurately focused onto the stone to cause stone fragmentation under direct visualization. The use of SpyGlass system with laser lithotripsy has been shown to be successful in the clearance of difficult bile duct stones in 73-100% patients.
Although various methods for removal of bile duct stones exist, there have been thus far no studies directly comparing endoscopic large balloon sphincteroplasty with cholangioscopy-guided laser lithotripsy for clearance of difficult bile duct stones. The aim of this study is therefore to compare the efficiency of the single-operator cholangioscopy-directed laser lithotripsy using the SpyGlass Direct Visualization system versus endoscopic large balloon sphincteroplasty for clearance of difficult bile duct stones.
- Conditions
- Common Bile Duct Stones
- Being tested
- Single-operator cholangioscopy-guided laser lithotripsy, Balloon Sphincteroplasty
- Keywords
- common bile duct stones, mechanical lithotripsy, balloon sphincteroplasty, single-operator cholangioscopy-guided laser lithotripy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-operator cholangioscopy-guided laser lithotripsyProcedure or surgery
Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
Balloon SphincteroplastyProcedure or surgery
Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Single-operator cholangioscopy guided laser lithotripsy | Active comparator | Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy Receives: Procedure: Single-operator cholangioscopy-guided laser lithotripsy |
| Balloon sphincteroplasty | Active comparator | Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy Receives: Procedure: Balloon Sphincteroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session using either the single-operator cholangioscopy-guided laser lithotripsy-based technique or large balloon sphincteroplasty-based technique
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session
Measured: 24 months
Secondary outcomes (3)
Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Safety is defined as the incidence of adverse events
Measured: 24 months
Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Costs include total costs pertaining to the treatment of bile duct stones including costs of procedure, medications, hospitalization, radiology, laboratory, anesthesia and supplies.
Measured: 24 months
Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Repeat interventions is defined as the need for more than one ERCP session for complete clearance of the bile duct of stones
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMar 2016
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
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 Common Bile Duct StonesStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852072
- Sponsor's protocol ID
- 718940
- Status last verified
- Oct 2019
- First submitted
- 25 Feb 2009
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript will be developed when the study is complete.
Publications
Bang JY, Sutton B, Navaneethan U, Hawes R, Varadarajulu S. Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2349-2356.e3. doi: 10.1016/j.cgh.2020.02.003. Epub 2020 Feb 10.
PubMed 32057976
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones
- ClinicalTrials.gov ID
- NCT00852072
- Acronym / sponsor ID
- 718940
- Conditions
- Common Bile Duct Stones
- Keywords
- common bile duct stones, mechanical lithotripsy, balloon sphincteroplasty, single-operator cholangioscopy-guided laser lithotripy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Feb 2009 (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.
Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty), mechanical lithotripsy or single-operator cholangioscopy guided laser lithotripsy techniques. There are currently no randomized trials comparing laser lithotripsy and sphincteroplasty techniques for the removal of difficult bile duct stones and the aim of this randomized trial is to determine which technique is superior in the removal of difficult bile duct stones.
Detailed description
Stones in the common bile duct (CBD) can result in various complications including acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. Bile duct stones should therefore be removed and this can be successfully achieved in 85-90% of patients with small bile duct stones using standard endoscopic techniques. This comprises endoscopic sphincterotomy whereby the duodenal sphincter at the entrance of the bile duct is cut during endoscopic retrograde cholangiopancreatography (ERCP) and subsequent removal of the stone is achieved using standard accessories such as a basket and/or extraction balloon. However, large/difficult bile duct stones (at least 12mm in size), multiple stones and those located in non-dilated bile ducts can be difficult to remove by endoscopic sphincterotomy and using only standard accessories. In such cases, the three most commonly practiced advanced maneuvers for extraction of difficult CBD stones are mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided laser lithotripsy (SOC-LL).
Endoscopic large balloon sphincteroplasty (using CRE Wireguided Balloon Dilatation Catheter; Boston Scientific Corp., Natick, MA, USA) is a technique in which a balloon is used to dilate the papilla located at the bile duct opening by up to 20mm (depending on size of the distal CBD) after performing an endoscopic sphincterotomy. Following dilation, the stone is removed using a basket and/or extraction balloon. This technique was shown to be effective in clearing the bile duct in 50-60% of patients with difficult bile stones in whom initial endoscopic sphincterotomy was unsuccessful.
The SpyGlass Direct Visualization System (Boston Scientific Corp., Natick, MA, USA) is a single-operator cholangioscopy system, which allows direct visualization of the bile duct stone. The main advantage of this technique is that the cholangioscope can be inserted into the endoscope and then guided through the bile duct to reach the stone. A probe can then be inserted into the cholangioscope to allow the energy from laser (laser lithotripsy) to be accurately focused onto the stone to cause stone fragmentation under direct visualization. The use of SpyGlass system with laser lithotripsy has been shown to be successful in the clearance of difficult bile duct stones in 73-100% patients.
Although various methods for removal of bile duct stones exist, there have been thus far no studies directly comparing endoscopic large balloon sphincteroplasty with cholangioscopy-guided laser lithotripsy for clearance of difficult bile duct stones. The aim of this study is therefore to compare the efficiency of the single-operator cholangioscopy-directed laser lithotripsy using the SpyGlass Direct Visualization system versus endoscopic large balloon sphincteroplasty for clearance of difficult bile duct stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-operator cholangioscopy guided laser lithotripsy | Active comparator | Procedure: Single-operator cholangioscopy-guided laser lithotripsyAbility to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy |
| Balloon sphincteroplasty | Active comparator | Procedure: Balloon SphincteroplastyAbility to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or over
- Common bile duct stones that measure at least 1.2 cm who have failed stone removal using standard techniques at ERCP
Key exclusion criteria (5 listed)
- Patients unable to provide informed consent due to any diminished capacity
- Pregnant patients or age < 18 years or prisoners
- Presence of bleeding disorders
- Patients with altered post-surgical anatomy
- Pregnancy
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 |
|---|---|---|
| Single-operator cholangioscopy-guided laser lithotripsyAbility to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy | Procedure or surgery | Single-operator cholangioscopy guided laser lithotripsy |
| Balloon SphincteroplastyAbility to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy | Procedure or surgery | Balloon sphincteroplasty |
Primary outcome
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session using either the single-operator cholangioscopy-guided laser lithotripsy-based technique or large balloon sphincteroplasty-based technique
Time frame: 24 months
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session
3 secondary outcomes
Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Time frame: 24 months
Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Time frame: 24 months
Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
Time frame: 24 months
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 10 Oct 2019.
- Derived from this study: PubMed 32057976Bang JY, Sutton B, Navaneethan U, Hawes R, Varadarajulu S. Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2349-2356.e3. doi: 10.1016/j.cgh.2020.02.003. Epub 2020 Feb 10.
- Individual participant dataSharing planned: Yes. A manuscript will be developed when the study is complete.
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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.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-operator cholangioscopy-guided laser lithotripsy and Balloon Sphincteroplasty in people with Common Bile Duct Stones, run by AdventHealth at 1 site in United States.
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 5 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session using either the single-operator cholangioscopy-guided laser lithotripsy-based technique or large balloon sphincteroplasty-based technique (time frame: 24 months). 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 NCT00852072, 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 10 Oct 2019.