The effect of tamsulosin on the spontaneous passage of bile stones

Phase 2

• Conditions: bilairy colic; choledocholithiasis; 10004606

• Registration Number: NL-OMON48799
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• 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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint will be to determine difference in stone expulsion rate<br /><br>with -and without Tamsulosin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Time to stone expulsion. The amount of time from the moment of diagnosis<br /><br>until passage of the stone in to the duodenum, will be compared between the<br /><br>placebo and Tamsulosin group.<br /><br>2. Stone expulsion rate in patients with cholangitis with -and without<br /><br>Tamsulosin (sub analysis). The rate of passage of biliary stones in to the<br /><br>duodenum will be compared between the placebo and Tamsulosin group.<br /><br>3. Adverse events<br /><br>4. Usage of morphine. </p><br>