Common Bile Duct StonesNCT02666820
Endoscopic Papillary Large Balloon Dilatation Versus Mechanical Lithotripsy for Large Stones
A study testing Large balloon dilatation and Mechanical lithotripsy in people with Common Bile Duct Stones, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stones
- What is being tested?
- Large balloon dilatation and Mechanical lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- uncorrectable coagulopathy (INR >1.5 ), thrombocytopenia( platelet count < 50,000)
- concomitant intrahepatic duct stones
- ongoing acute pancreatitis or acute cholecystitis
- surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
- concomitant pancreatic or biliary malignancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Endoscopic Papillary Large Balloon Dilatation Versus Sphincterotomy +/- Mechanical Lithotripsy for Removal of Bile Duct Stones With a Mean Stone > 20 mm : A Randomized Controlled Study
Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.
Read the detailed description
The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size > 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS > 15 mm with a mean stone size > 20 mm.
- Conditions
- Common Bile Duct Stones
- Being tested
- Large balloon dilatation, Mechanical lithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large balloon dilatationProcedure or surgery
After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.
Mechanical lithotripsyProcedure or surgery
After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.
| Study group | Role | What they receive |
|---|---|---|
| Large balloon dilatation | Active comparator | Patients underwent clearance of common bile duct stones using a papillary large balloon dilatation. Receives: Procedure: Large balloon dilatation |
| Mechanical lithotripsy | Active comparator | Patients underwent clearance of common bile duct stones using a mechanical lithotripsy. Receives: Procedure: Mechanical lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete stone clearance rate in the index ERCP
The number of patients who was achieved complete stone clearance in the index ERCP
Measured: 24 hours
Secondary outcomes (3)
Procedure time
The procedure time was the time between insertion of the index device namely, a balloon or ML, and occlusion of cholangiogram
Measured: 24 hours
Complete stone clearance rate in the rescue therapy
The number of patients who was achieved complete stone clearance in the rescue therapy
Measured: 24 hours
Complication rate
The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2010
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Bancha Ovartlarnporn, MD., Study director, NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666820
- Sponsor's protocol ID
- 53-170-14-3-2
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Papillary Large Balloon Dilatation Versus Sphincterotomy +/- Mechanical Lithotripsy for Removal of Bile Duct Stones With a Mean Stone > 20 mm : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02666820
- Acronym / sponsor ID
- 53-170-14-3-2
- Conditions
- Common Bile Duct Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jan 2016 (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.
Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been increasingly accepted as alternative method for removal of large bile duct stones. However, there were limited studies comparing the efficacy of EST in combined with LBD to EST with mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of combined EST- LBD versus EST-ML in the removal of very large bile duct stones.
Detailed description
The large common bile duct stones (CBDS) remains a therapeutic challenge in ERCPs. Large CBDS are generally refractory to be removed by EST and stone extraction balloons and or baskets. Traditional rescue therapy was the technique of stone fragmentation using ML. The previous reports have shown that EST with ML was successful in the fragmentation of large stones yielding stone clearance rate from 68 t0 79 %. EST-LBD has been shown favorable outcome in the treatment of large bile duct stone. A meta-analysis comparing the effectiveness and complications between EST-LBD and EST in the management of CBDS showed that EST-LBD was as effective as EST for the removal of large or difficult of CBDS in terms of stone clearance in the first ERCP session of 87.87 % vs. 84.15 % and overall clearance of 97.35 % vs. 96.35 % but EST-LBD was associated with fewer complications as well as reduced need for ML compared to EST. The efficacy of EST-ML versus EST-LBD as a therapy for relatively large CBDS, a mean stone size > 20 mm in currently not well defined. The investigators, herein, compared the efficacy and complications between EST followed by LBD or ML for the removal of CBDS > 15 mm with a mean stone size > 20 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large balloon dilatation | Active comparator | Procedure: Large balloon dilatationPatients underwent clearance of common bile duct stones using a papillary large balloon dilatation. |
| Mechanical lithotripsy | Active comparator | Procedure: Mechanical lithotripsyPatients underwent clearance of common bile duct stones using a mechanical lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- uncorrectable coagulopathy (INR >1.5 ), thrombocytopenia( platelet count < 50,000)
- concomitant intrahepatic duct stones
- ongoing acute pancreatitis or acute cholecystitis
- surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction)
- concomitant pancreatic or biliary malignancy
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 |
|---|---|---|
| Large balloon dilatationAfter biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists. | Procedure or surgery | Large balloon dilatation |
| Mechanical lithotripsyAfter biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists. | Procedure or surgery | Mechanical lithotripsy |
Primary outcome
Complete stone clearance rate in the index ERCP
Time frame: 24 hours
The number of patients who was achieved complete stone clearance in the index ERCP
3 secondary outcomes
Procedure time
Time frame: 24 hours
Complete stone clearance rate in the rescue therapy
Time frame: 24 hours
Complication rate
Time frame: 30 days
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 29 Jan 2016.
- Individual participant dataSharing planned: No. The individual data of patients participating in the study are not available for public sharing since we did not obtain the consent to share the data of patient
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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.
Bancha Ovartlarnporn, MD. study director
NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large balloon dilatation and Mechanical lithotripsy in people with Common Bile Duct Stones, run by Prince of Songkla University at 1 site 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 0 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 29 Jan 2016. 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 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?
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?
Complete stone clearance rate in the index ERCP (time frame: 24 hours). 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 29 Jan 2016.