The effect of tamsulosin on the spontaneous passage of bile stones

The effect of tamsulosin on the spontaneous passage of bile stones - TASTE

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001380-23-NL

Enrollment

350

Registered

2019-07-03

Start date

2020-02-21

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 In case of a high suspicion of stones at the moment of EUS	—

Measure

Time frame

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 In case of a high suspicion of stones at the moment of EUS

—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Contacts

Public ContactRobert Roomer

Franciscus Gasthuis en Vlietland

r.roomer@franciscus.nl0031104616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026