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Flushing of internalized percutaneous transhepatic biliary drainage catheters

Recruiting
Conditions
biliary obstruction
10019654
Registration Number
NL-OMON54445
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
91
Inclusion Criteria

- Patient with obstruction of the bile duct(s) planned for internal external
PTBD;
- Proficient in Dutch language;
- Written informed consent.

Exclusion Criteria

- Age < 18 years;
- No informed consent;
- Pregnancy;
- Obstruction caused by gall stones;
- External PTBD catheter (without internalization);
- Patient has already a PTBD catheter;
- More than 1 PTBD catheter is placed at intervention.
- If the patient is non-communicative.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Median time-to-symptom-onset in patients with an internal external PTBD<br /><br>catheter without daily flushing compared to patients with an internal external<br /><br>PTBD catheter who daily flush the catheter</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Comparison of the number of re-interventions<br /><br>- Comparison of the events of cholangitis<br /><br>- Comparison of the decrease in bilirubin<br /><br>- Comparison of the quality of life<br /><br>- Comparison of the cost-effectiveness<br /><br>- Comparison of the mortality rate<br /><br>- Comparison of the number of catheter complications<br /><br>- Therapy adherence</p><br>
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