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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESLBD | Active Comparator | Endoscopic Sphincterotomy plus Large Balloon Dilatation +/- lithotripsy
|
|
| CONV | Active Comparator | Conventional treatment associating Endoscopic Sphincterotomy +/- Mechanical Lithotripsy (ES+/-LM)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP | Procedure | Common bile duct cannulation with a cannulation catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with mild or severe BLEEDING (Morbidity) after ERCP | Immediate complications were noted :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David KARSENTI, MD | Société Française d'Endoscopie Digestive | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28753698 | Derived | 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. |
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| Endoscopic Sphincterotomy | Procedure | Endoscopic large sphincterotomy |
|
|
| Large Balloon Dilatation of Oddi Sphincter | Device | Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter) |
|
|
| Stone extraction | Procedure | After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed |
|
| 1 month |
| Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP | Immediate complications were noted :
| 1 month |
| Number of patients with PERFORATION (Morbidity of ERCP) |
| 1 day |
| Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP) |
| 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 | 1 month |
| MORTALITY of ERCP | - Number of death happened in both groups during the first month after the procedure were noted and compared | 1 month |
| Number of patients with recurrence of BDS |
| 1 month |
| Length of procedure | For each patient, time was noted at the beginning and at the end of ERCP | 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 | 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 | Day one |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D016717 | Sphincterotomy, Endoscopic |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D001662 | Biliary Tract Surgical Procedures |
| D016099 | Endoscopy, Gastrointestinal |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
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