Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones
NCT ID: NCT02592811
Last Updated: 2015-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2010-07-31
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESLBD
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
ERCP
Common bile duct cannulation with a cannulation catheter
Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Large Balloon Dilatation of Oddi Sphincter
Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
CONV
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
ERCP
Common bile duct cannulation with a cannulation catheter
Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
Interventions
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ERCP
Common bile duct cannulation with a cannulation catheter
Endoscopic Sphincterotomy
Endoscopic large sphincterotomy
Large Balloon Dilatation of Oddi Sphincter
Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Société Française d'Endoscopie Digestive
OTHER
Responsible Party
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KARSENTI
MD
Principal Investigators
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David KARSENTI, MD
Role: PRINCIPAL_INVESTIGATOR
Société Française d'Endoscopie Digestive
References
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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.
Other Identifiers
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SocieteFranceED
Identifier Type: -
Identifier Source: org_study_id