The effect of tamsulosin on the spontaneous passage of bile stones

Phase 1

• Conditions: Choledocholithiasis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001380-23-NL
• Lead Sponsor: Franciscus Gasthuis en Vlietland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-03
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

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

Exclusion Criteria

-Patients already using Tamsulosin
-Patients participating in other trials
-Pregnancy (description procedure below)
-Patients presenting with a pancreatitis
-Patients with a previous papillotomy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: to determine difference in stone expulsion rate 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.;Primary end point(s): Spontaneous stone passage with and without tamsulosin;Timepoint(s) of evaluation of this end point: In case of proven stones at the moment of ERCP<br>In case of a high suspicion of stones at the moment of EUS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Time to stone expulsion<br>2.Stone expulsion rate in patients with cholangitis with and without Tamsulosin<br>3.Adverse events <br>4.Usage of morphine<br>;Timepoint(s) of evaluation of this end point: In the days after admission until discharge from the hospital