Bile LeakageNCT01960712
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
A study testing Transpapillary plastic stent (7-10 Fr) in people with Bile Leakage, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bile Leakage
- What is being tested?
- Transpapillary plastic stent (7-10 Fr)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to May 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver resection including at least two liver segments.
Who cannot join
- Hepatobiliary digestive anastomosis.
Trial locations and contacts
1 site in 1 country.
About this study
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.
Read the detailed description
All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.
- Conditions
- Bile Leakage
- Being tested
- Transpapillary plastic stent (7-10 Fr)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpapillary plastic stent (7-10 Fr)Device
Duodenoscopy plus transpapillary bile cannulation plus stent insertion.
| Study group | Role | What they receive |
|---|---|---|
| Continued external drainage | No intervention | Continued external drainage alone. |
| Continued external drainage + transpapillary stent | Active comparator | External drainage + transpapillary plastic stent (7-10 Fr). Receives: Device: Transpapillary plastic stent (7-10 Fr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of bile leakage from the abdominal cavity
Measured: From intervention until day discharge from hospital
Secondary outcomes (1)
General complications rates. Postoperative hospital stay
Measured: From intervention until day of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startNov 2008
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile LeakageStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jansson, Anders, M.D.
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars Lundell, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960712
- Sponsor's protocol ID
- 2006/1142-31/3
- Other IDs
- 2006/1142-31/3
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2013
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
- ClinicalTrials.gov ID
- NCT01960712
- Acronym / sponsor ID
- 2006/1142-31/3
- Conditions
- Bile Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Jansson, Anders, M.D.
- Study start
- Nov 2008
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Oct 2013 (estimated)
- 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.
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.
Detailed description
All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued external drainage | No intervention | –Continued external drainage alone. |
| Continued external drainage + transpapillary stent | Active comparator | Device: Transpapillary plastic stent (7-10 Fr)External drainage + transpapillary plastic stent (7-10 Fr). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver resection including at least two liver segments.
Key exclusion criteria (1 listed)
- Hepatobiliary digestive anastomosis.
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 |
|---|---|---|
| Transpapillary plastic stent (7-10 Fr)Duodenoscopy plus transpapillary bile cannulation plus stent insertion. | Device | Continued external drainage + transpapillary stent |
Primary outcome
Number of days of bile leakage from the abdominal cavity
Time frame: From intervention until day discharge from hospital
1 secondary outcome
General complications rates. Postoperative hospital stay
Time frame: From intervention until day of discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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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.
Lars Lundell, Professor principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpapillary plastic stent (7-10 Fr) in people with Bile Leakage, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2020. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of bile leakage from the abdominal cavity (time frame: From intervention until day discharge from hospital). 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 6 Oct 2020.