The effect of tamsulosin on the spontaneous passage of bile stones

INTERVENTION: Trade Name: Tamsulijn 0.4 mg Product Name: Tamsulosin Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Choledocholithiasis Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: Primary objective: to determine difference in stone expulsion rate with and without Tamsulosin. Primary end point(s): Spontaneous stone passage with and without tamsulosin Secondary Objective: Secondary objectives: 1. Time to stone expulsion; 2. Stone expulsion rate in patients with cholangitis; 3. Adverse events; 4. Usage of morphine. Timepoint(s) of evaluation of this end point: In case of proven stones at the moment of ERCP; In case of a high suspicion of stones at the moment of EUS SECONDARY OUTCOME: Secondary end point(s): 1. Time to stone expulsion ; 2. Stone expulsion rate in patients with cholangitis with and without Tamsulosin ; 3. Adverse events ; 4. Usage of morphine ; Timepoint(s) of evaluation of this end point: In the days after admission until discharge from the hospital INCLUSION CRITERIA: ‐ Choledocholithiasis (definition below) ‐ Age =18 years ‐ Written informed consent Definition of choledocholithiasis, at least 2 of the following criteria: ‐ Choledocholithiasis (proven on CT/US/MR) ‐ Colic pain ‐ Bilirubin = 40 µmol/L OR ALAT = 2 times upper limit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100