Bile Duct ObstructionFLUSHNCT04915703
Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
A study testing Flushing of PTBD catheter in people with Bile Duct Obstruction, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Obstruction
- What is being tested?
- Flushing of PTBD catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with obstruction of the bile duct(s) planned for internal external PTBD;
- Proficient in Dutch language;
- Written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
ErasmusMC
Rotterdam, South Holland, 3015CE
About this study
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. The onset of these symptoms results in hospital visits, opening of the external catheter of an internal external PTBD and re-interventions.
The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset.
Read the detailed description
Bile is synthesized and secreted by the liver and transported into the peripheral bile ducts, to the left or right hepatic duct which join together in the common hepatic duct and more distally in the common bile duct. Secreted bile is stored in the gall bladder. During a meal, the bile is secreted into the duodenum.
Obstruction of the biliary tract will result in cholestasis with symptoms as jaundice and pruritus and cholangitis in case of infection, usually related to prior biliary intervention. Causes of biliary obstruction are benign or malignant.
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. The procedure starts with percutaneous puncture under fluoroscopic or ultrasound guidance and cannulation of the peripheral biliary tree, which is confirmed by contrast injection in the biliary tree. The needle will be exchanged for a guidewire which can be advanced into the biliary tract. When the correct position is reached, a drainage catheter with side holes is placed.
There are two types of PTBD techniques: placement of an external biliary drain and placement of an internal external biliary drain. The external biliary drain is positioned in the bile duct above a stenosis and drains the bile externally into a bag outside the patient. Capping of an external biliary drain will stop the drainage of bile into the bag and forces the bile to drain towards the digestive tract. The internal external biliary drain is placed in the bile duct and the tip of the internal external biliary drain is localised in the duodenum allowing both bile flow through the drain to the digestive tract (internal) or into the bag (external). Capping of an internal external biliary drain will stop the external drainage and results in internal drainage only.
Complications of PTBD are bleeding (usually during or shortly after the procedure), infection (cholangitis, abscess, peritonitis, cholecystitis, pancreatitis), catheter obstruction and catheter dislocation(1). Catheter obstruction will result in cholestasis resulting in jaundice, drain leakage and finally cholangitis. The exact prevalence of PTBD catheter obstruction is not described in literature, however the prevalence of cholangitis in patients with a PTBD catheter is reported as high as 59%(2). Subsequently, the PTBD catheter often needs a revision (re-intervention), i.e. exchanging the catheter for a new one. If catheter obstruction is assessed during re-intervention, attempts can be made to remove the obstruction or the obstructed PTBD catheter can be exchanged for a new PTBD catheter.
After PTBD catheter placement, flushing of the PTBD catheter is not standard protocol in our center. In clinical practice, when obstruction of PTBD catheter occurs, the study team will advise patients to start with daily flushing of the PTBD catheter which the investigators believe will decrease the extent of obstruction and omits re-intervention. The investigators performed a literature search and the investigators did not find any clinical trial on the efficacy of flushing of PTBD catheters. Guidelines of the Society of Interventional Radiology on percutaneous biliary drainage do not mention flushing of the catheter(1). The investigators did find some publications in which an advice with regard to flushing of a PTBD catheter was mentioned, however without any scientific substantiation(3-7).
There is no scientific evidence for or against PTBD catheter flushing. Flushing is a simple, low-cost and low-risk procedure. Complications or side-effects of PTBD catheter flushing are not reported in literature. PTBD re-interventions on the other hand are associated with risks and are invalidating for the patient. The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset requiring hospital visits and re-interventions in this patient group.
- Conditions
- Bile Duct Obstruction
- Being tested
- Flushing of PTBD catheter
- Keywords
- bile duct, obstruction
- Medical subject headings
- Cholestasis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flushing of PTBD catheterProcedure or surgery
flushing of internal external PTBD catheter 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | flushing of internal external PTBD catheter 3 times a day Receives: Procedure: Flushing of PTBD catheter |
| Standard of Care | No intervention | no flushing of PTBD catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter
time-to-symptom-onset
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded randomized controlled trial with 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriaan Moelker, Erasmus Medical Center
- Investigators
- laurens Groenendijk, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915703
- Sponsor's protocol ID
- NL77857.078.21
- Acronym
- FLUSH
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
- ClinicalTrials.gov ID
- NCT04915703
- Acronym / sponsor ID
- FLUSH / NL77857.078.21
- Conditions
- Bile Duct Obstruction
- Keywords
- bile duct, obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. The onset of these symptoms results in hospital visits, opening of the external catheter of an internal external PTBD and re-interventions.
The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset.
Detailed description
Bile is synthesized and secreted by the liver and transported into the peripheral bile ducts, to the left or right hepatic duct which join together in the common hepatic duct and more distally in the common bile duct. Secreted bile is stored in the gall bladder. During a meal, the bile is secreted into the duodenum.
Obstruction of the biliary tract will result in cholestasis with symptoms as jaundice and pruritus and cholangitis in case of infection, usually related to prior biliary intervention. Causes of biliary obstruction are benign or malignant.
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. The procedure starts with percutaneous puncture under fluoroscopic or ultrasound guidance and cannulation of the peripheral biliary tree, which is confirmed by contrast injection in the biliary tree. The needle will be exchanged for a guidewire which can be advanced into the biliary tract. When the correct position is reached, a drainage catheter with side holes is placed.
There are two types of PTBD techniques: placement of an external biliary drain and placement of an internal external biliary drain. The external biliary drain is positioned in the bile duct above a stenosis and drains the bile externally into a bag outside the patient. Capping of an external biliary drain will stop the drainage of bile into the bag and forces the bile to drain towards the digestive tract. The internal external biliary drain is placed in the bile duct and the tip of the internal external biliary drain is localised in the duodenum allowing both bile flow through the drain to the digestive tract (internal) or into the bag (external). Capping of an internal external biliary drain will stop the external drainage and results in internal drainage only.
Complications of PTBD are bleeding (usually during or shortly after the procedure), infection (cholangitis, abscess, peritonitis, cholecystitis, pancreatitis), catheter obstruction and catheter dislocation(1). Catheter obstruction will result in cholestasis resulting in jaundice, drain leakage and finally cholangitis. The exact prevalence of PTBD catheter obstruction is not described in literature, however the prevalence of cholangitis in patients with a PTBD catheter is reported as high as 59%(2). Subsequently, the PTBD catheter often needs a revision (re-intervention), i.e. exchanging the catheter for a new one. If catheter obstruction is assessed during re-intervention, attempts can be made to remove the obstruction or the obstructed PTBD catheter can be exchanged for a new PTBD catheter.
After PTBD catheter placement, flushing of the PTBD catheter is not standard protocol in our center. In clinical practice, when obstruction of PTBD catheter occurs, the study team will advise patients to start with daily flushing of the PTBD catheter which the investigators believe will decrease the extent of obstruction and omits re-intervention. The investigators performed a literature search and the investigators did not find any clinical trial on the efficacy of flushing of PTBD catheters. Guidelines of the Society of Interventional Radiology on percutaneous biliary drainage do not mention flushing of the catheter(1). The investigators did find some publications in which an advice with regard to flushing of a PTBD catheter was mentioned, however without any scientific substantiation(3-7).
There is no scientific evidence for or against PTBD catheter flushing. Flushing is a simple, low-cost and low-risk procedure. Complications or side-effects of PTBD catheter flushing are not reported in literature. PTBD re-interventions on the other hand are associated with risks and are invalidating for the patient. The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset requiring hospital visits and re-interventions in this patient group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded randomized controlled trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Flushing of PTBD catheterflushing of internal external PTBD catheter 3 times a day |
| Standard of Care | No intervention | –no flushing of PTBD catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with obstruction of the bile duct(s) planned for internal external PTBD;
- Proficient in Dutch language;
- Written informed consent.
Key exclusion criteria (7 listed)
- Age < 18 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flushing of PTBD catheterflushing of internal external PTBD catheter 3 times a day | Procedure or surgery | Intervention |
Primary outcome
time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter
Time frame: 12 weeks
time-to-symptom-onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
laurens Groenendijk study director
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flushing of PTBD catheter in people with Bile Duct Obstruction, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact laurens Groenendijk (31 0 7033612, l.groenendijk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.