CholedocholithiasisPhase 3NCT02592811
Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones
A Phase 3 study testing ERCP, Endoscopic Sphincterotomy and Large Balloon Dilatation of Oddi Sphincter in people with Choledocholithiasis and Large Common Bile Duct Stone, run by Société Française d'Endoscopie Digestive.
Trial summary
Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Large Common Bile Duct Stone
- What is being tested?
- ERCP, Endoscopic Sphincterotomy and Large Balloon Dilatation of Oddi Sphincter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Mar 2015
- Phase
- Phase 3
- 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
- Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram
Who cannot join
- Active or history of acute pancreatitis
- Presence of intrahepatic stones
- History of Billroth II or roux-en-Y reconstruction
- Coagulation disorder (partial thromboplastin time > 42 seconds, prothrombin time (Quick value) < 50% and platelet count of <50 000/mm3)
- Current anticoagulation or clopidogrel treatment
- Pregnancy
- Inability to give informed consent
About this study
Official title: Endoscopic Sphincterotomy Plus Large-Balloon Dilatation (ESLBD) Versus Conventional Endoscopic Treatment for Removal of Large Common Bile Duct Stones : A Prospective Comparative Multi Center Randomized Study
Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the safety of ESLBD is accepted in all recent published studies, it remains controversial wether ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones. Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.
The purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.
- Conditions
- Choledocholithiasis, Large Common Bile Duct Stone
- Being tested
- ERCP, Endoscopic Sphincterotomy, Large Balloon Dilatation of Oddi Sphincter, Stone extraction
- Keywords
- Cholangiopancreatography, therapeutic strategy, Endoscopic Retrograde
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called Cholangiogram with deep cannulation of CBD
Common bile duct cannulation with a cannulation catheter
Endoscopic SphincterotomyProcedure or surgery
Also called ES
Endoscopic large sphincterotomy
Large Balloon Dilatation of Oddi SphincterDevice
Also called LBD, LBDS
Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
Stone extractionProcedure or surgery
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
| Study group | Role | What they receive |
|---|---|---|
| ESLBD | Active comparator | Endoscopic Sphincterotomy plus Large Balloon Dilatation +/- lithotripsy
1. ERCP with deep cancellation of BDS
2. Endoscopic large sphincterotomy
3. Large Balloon Dilatation of Oddi Sphincter: with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
4. Stone extraction with dormia basket or extraction balloon
5. Mechanical Lithotripsy if needed Receives: Procedure: ERCP; Procedure: Endoscopic Sphincterotomy; Device: Large Balloon Dilatation of Oddi Sphincter; Procedure: Stone extraction |
| CONV | Active comparator | Conventional treatment associating Endoscopic Sphincterotomy +/- Mechanical Lithotripsy (ES+/-LM)
1. ERCP with deep cancellation of BDS
2. Endoscopic large sphincterotomy
3. Stone extraction with dormia basket or extraction balloon
4. Mechanical Lithotripsy if needed Receives: Procedure: ERCP; Procedure: Endoscopic Sphincterotomy; Procedure: Stone extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
Measured: 1 month
Secondary outcomes (10)
Number of patients with mild or severe BLEEDING (Morbidity) after ERCP
Immediate complications were noted :
- bleeding : mild if blood transfusion not necessary, and severe if blood transfusion necessary
- Clinical data (pain, fever, vomiting...) are noted during first month
- Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
- In case of bleeding suspected, a new ERCP was done
- Number of patients with bleeding and with any complication in both groups were noted and compared
Measured: 1 month
Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP
Immediate complications were noted :
- Acute pancreatitis : defined by the association of abdominal pain and lipase blood test > 3 N
- Severity of acute pancreatitis was evaluated on CT index, and on evolution data
- Clinical data (pain, fever, vomiting...) are noted during first month
- Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
- Abdominal CT was performed in case of suspected acute pancreatitis
- Number of patients with Acute Pancreatitis and any complication in both groups were noted and compared
Measured: 1 month
Number of patients with PERFORATION (Morbidity of ERCP)
- Suspected on clinical data (pain, fever, vomiting...) and blood tests (Blood count, C reactive protein) noted during first day after ERCP:
- confirmed on CT
- Number of patients with perforation in both groups were noted and compared, and global morbidity in both groups were noted and compared
Measured: 1 day
Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)
- Suspected on clinical data (pain, fever, vomiting...), blood tests (Blood count, C reactive protein, blood and urine cultures), noted during first day after ERCP, during 30th day and more if necessary in the meantime
- Abdominal US and CT were performed if necessary
- Number of patients with infection in both groups were noted and compared, and global morbidity in both groups were noted and compared
Measured: 1 month
GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)
- Number of patients with any complication as bleeding, acute pancreatitis, perforation, infection (as angiocholitis, cholecystitis, urine infection or septicemia) happened in both groups during the first month after the procedure were noted and compared
Measured: 1 month
MORTALITY of ERCP
- Number of death happened in both groups during the first month after the procedure were noted and compared
Measured: 1 month
Number of patients with recurrence of BDS
- Clinical data (pain, fever, vomiting...) are noted during first month
- Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure
- In case of recurrence BDS suspected, abdominal US and/or CT and/or MRI and/or EUS (Endoscopic Ultrasonography) were done, and if BDS was confirmed, a new ERCP was done
- Number of patients with recurrence of BDS in both groups in the first month after the procedure were noted and compared
Measured: 1 month
Length of procedure
For each patient, time was noted at the beginning and at the end of ERCP
Measured: Day one
Cost of procedure
All the instrument used during ERCP (endoscopic retrograde cholangiopancreatography) for each patient were noted, and at the end of procedure cost of all instruments were recorded
Measured: Day one
comparison of the frequency of mechanical lithotripsy of both groups
In both groups mechanical lithotripsy can be performed in case of impossibility of stone extraction. The rate of lithotripsy performed in both groups were compared
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJul 2010
- Primary completionMar 2015
- Study completionMar 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
- Investigators
- David KARSENTI, MD, Principal investigator, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592811
- Sponsor's protocol ID
- SocieteFranceED
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karsenti D, Coron E, Vanbiervliet G, Privat J, Kull E, Bichard P, Perrot B, Quentin V, Duriez A, Cholet F, Subtil C, Duchmann JC, Lefort C, Hudziak H, Koch S, Granval P, Lecleire S, Charachon A, Barange K, Cesbron EM, De Widerspach A, Le Baleur Y, Barthet M, Poincloux L. Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study. Endoscopy. 2017 Oct;49(10):968-976. doi: 10.1055/s-0043-114411. Epub 2017 Jul 28.
PubMed 28753698
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sphincterotomy Plus Large-Balloon Dilatation (ESLBD) Versus Conventional Endoscopic Treatment for Removal of Large Common Bile Duct Stones : A Prospective Comparative Multi Center Randomized Study
- ClinicalTrials.gov ID
- NCT02592811
- Acronym / sponsor ID
- SocieteFranceED
- Conditions
- Choledocholithiasis, Large Common Bile Duct Stone
- Keywords
- Cholangiopancreatography, therapeutic strategy, Endoscopic Retrograde
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Oct 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.
Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the safety of ESLBD is accepted in all recent published studies, it remains controversial wether ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones. Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.
The purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESLBD | Active comparator | Procedure: ERCP, Procedure: Endoscopic Sphincterotomy, Device: Large Balloon Dilatation of Oddi Sphincter, Procedure: Stone extractionEndoscopic Sphincterotomy plus Large Balloon Dilatation +/- lithotripsy 1. ERCP with deep cancellation of BDS 2. Endoscopic large sphincterotomy 3. Large Balloon Dilatation of Oddi Sphincter: with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter) 4. Stone extraction with dormia basket or extraction balloon 5. Mechanical Lithotripsy if needed |
| CONV | Active comparator | Procedure: ERCP, Procedure: Endoscopic Sphincterotomy, Procedure: Stone extractionConventional treatment associating Endoscopic Sphincterotomy +/- Mechanical Lithotripsy (ES+/-LM) 1. ERCP with deep cancellation of BDS 2. Endoscopic large sphincterotomy 3. Stone extraction with dormia basket or extraction balloon 4. Mechanical Lithotripsy if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram
Key exclusion criteria (7 listed)
- Active or history of acute pancreatitis
- Presence of intrahepatic stones
- History of Billroth II or roux-en-Y reconstruction
- Coagulation disorder (partial thromboplastin time > 42 seconds, prothrombin time (Quick value) < 50% and platelet count of <50 000/mm3)
- Current anticoagulation or clopidogrel treatment
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 |
|---|---|---|
| ERCPAlso: Cholangiogram with deep cannulation of CBDCommon bile duct cannulation with a cannulation catheter | Procedure or surgery | CONV, ESLBD |
| Endoscopic SphincterotomyAlso: ESEndoscopic large sphincterotomy | Procedure or surgery | CONV, ESLBD |
| Large Balloon Dilatation of Oddi SphincterAlso: LBD, LBDSLarge Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter) | Device | ESLBD |
| Stone extractionAfter dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed | Procedure or surgery | CONV, ESLBD |
Primary outcome
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
Time frame: 1 month
10 secondary outcomes
Number of patients with mild or severe BLEEDING (Morbidity) after ERCP
Time frame: 1 month
Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP
Time frame: 1 month
Number of patients with PERFORATION (Morbidity of ERCP)
Time frame: 1 day
Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)
Time frame: 1 month
GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)
Time frame: 1 month
MORTALITY of ERCP
Time frame: 1 month
Number of patients with recurrence of BDS
Time frame: 1 month
Length of procedure
Time frame: Day one
Cost of procedure
Time frame: Day one
comparison of the frequency of mechanical lithotripsy of both groups
Time frame: Day one
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 30 Oct 2015.
- Derived from this study: PubMed 28753698Karsenti D, Coron E, Vanbiervliet G, Privat J, Kull E, Bichard P, Perrot B, Quentin V, Duriez A, Cholet F, Subtil C, Duchmann JC, Lefort C, Hudziak H, Koch S, Granval P, Lecleire S, Charachon A, Barange K, Cesbron EM, De Widerspach A, Le Baleur Y, Barthet M, Poincloux L. Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study. Endoscopy. 2017 Oct;49(10):968-976. doi: 10.1055/s-0043-114411. Epub 2017 Jul 28.
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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.
David KARSENTI, MD principal investigator
Société Française d'Endoscopie Digestive
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ERCP, Endoscopic Sphincterotomy and Large Balloon Dilatation of Oddi Sphincter in people with Choledocholithiasis and Large Common Bile Duct Stone, run by Société Française d'Endoscopie Digestive.
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 7 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 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography) (time frame: 1 month). 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 NCT02592811, 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 30 Oct 2015.