Clinical trial NCT02592811: Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choledocholithiasis
Large Common Bile Duct Stone
Keywords: Cholangiopancreatography
therapeutic strategy
Endoscopic Retrograde
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Patient with CBD stones with a smaller diameter ≥ 13mm on cholangiogram

Exclusion Criteria:

* 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

Primary outcomes:
measure: Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)
timeFrame: 1 month
Secondary outcomes:
measure: Number of patients with mild or severe BLEEDING (Morbidity) after ERCP
timeFrame: 1 month
measure: Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP
timeFrame: 1 month
measure: Number of patients with PERFORATION (Morbidity of ERCP)
timeFrame: 1 day
measure: Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)
timeFrame: 1 month
measure: GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)
timeFrame: 1 month
measure: MORTALITY of ERCP
timeFrame: 1 month
measure: Number of patients with recurrence of BDS
timeFrame: 1 month
measure: Length of procedure
timeFrame: Day one
measure: Cost of procedure
timeFrame: Day one
measure: comparison of the frequency of mechanical lithotripsy of both groups
timeFrame: Day one
Other outcomes:
Locations:
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: David KARSENTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.