Flushing internal biliary drainage catheters to reduce symptoms
Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
This study is testing if daily flushing of biliary drainage catheters can help people with bile duct blockages avoid symptoms like pain and jaundice for longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, Zuid Holland) |
| Trial ID | NCT04915703 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of daily flushing of internal external percutaneous transhepatic biliary drainage (PTBD) catheters in patients with bile duct obstruction. The goal is to prolong the time before patients experience symptoms such as pain, jaundice, and fever, which often lead to hospital visits and re-interventions. The study will involve patients who are proficient in Dutch and have given informed consent, focusing on those with planned internal external PTBD. The methodology includes monitoring symptom onset and the need for additional interventions following the flushing protocol.
Who should consider this trial
Good fit: Ideal candidates are patients with bile duct obstruction who are planned for internal external PTBD and can communicate in Dutch.
Not a fit: Patients who have obstruction caused by gallstones or those with external PTBD catheters will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of hospital visits and improve the quality of life for patients with bile duct obstruction.
How similar studies have performed: While similar approaches have been explored, this specific flushing protocol for internal external PTBD catheters is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rotterdam, Zuid Holland
- ErasmusMC — Rotterdam, Zuid Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: laurens Groenendijk
- Email: l.groenendijk@erasmusmc.nl
- Phone: 31 0 7033612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.