EUS Guided Biliary DrainageNCT04024930
Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]
An observational study of EUS Guided Biliary Drainage, run by University Hospital, Limoges at 8 sites in France.
Trial summary
Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EUS Guided Biliary Drainage
- How many people
- 70 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Sep 2017to 30 Oct 2018
- Phase
- Observational
- 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
Study population: patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS
Who may be able to join
- patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS
Who cannot join
- < 18 years old
- refusal to participate
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hospital University
Brest, 29600
University Hospital
Limoges, 87042
Hospital Private Jean MERMOZ
Lyon, 69008
APHM Hospital La Timone
Marseille, 29600
University Hospital
Montpellier, 34295
APHP Hospital Saint-Antoine
Paris, 75012
Hospital Cournouaille
Quimper, 29000
Hospital Jacques Lacarin
Vichy, 03200
About this study
Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.
- Conditions
- EUS Guided Biliary Drainage
- Keywords
- EUS guided biliairy drainage, EUS Choledoco-duodenostomy, Axios stent, Lumen Apposing Metal Stent
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success rate
Technical success was defined as the ability to correctly deploy the Hot AXIOS stent between the common bile duct and the duodenal bulb with visualization of bile flow
Measured: Day 1
Secondary outcomes (5)
Clinical success
Number of participants with a decrease in the bilirubin level ≥ 50% at day 7, or normalization at day 28
Measured: Day 28
Periprocedural adverse events: adverse events that occur during the procedure
Number of participants with an adverse event occuring during the procedure of EUS-CDS. ASGE lexicon will be used to grade these adverse events.
Measured: Day 1
short-term adverse events
Number of participants with an adverse event occuring between the procedure and discharge from hospital. Adverse events were rated according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon will be used to grade these adverse events.
Measured: Day 7
Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.
Number of participants with a biliary adverse event occuring after discharge from hospital. Adverse events were rated according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon will be used to grade these adverse events.
Measured: Year 1
Six month stent patency rate
rate of permeability of the stent 6 months after the procedure
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Sep 2017
- Primary completion30 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EUS Guided Biliary DrainageStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024930
- Sponsor's protocol ID
- 87RI18_0034
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]
- ClinicalTrials.gov ID
- NCT04024930
- Acronym / sponsor ID
- 87RI18_0034
- Conditions
- EUS Guided Biliary Drainage
- Keywords
- EUS guided biliairy drainage, EUS Choledoco-duodenostomy, Axios stent, Lumen Apposing Metal Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Jul 2019 (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.
Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS
Key inclusion criteria (1 listed)
- patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS
Key exclusion criteria (2 listed)
- < 18 years old
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
technical success rate
Time frame: Day 1
Technical success was defined as the ability to correctly deploy the Hot AXIOS stent between the common bile duct and the duodenal bulb with visualization of bile flow
5 secondary outcomes
Clinical success
Time frame: Day 28
Periprocedural adverse events: adverse events that occur during the procedure
Time frame: Day 1
short-term adverse events
Time frame: Day 7
Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.
Time frame: Year 1
Six month stent patency rate
Time frame: Month 6
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 18 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EUS Guided Biliary Drainage, run by University Hospital, Limoges at 8 sites in France.
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 2 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
technical success rate (time frame: Day 1). 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 18 Jul 2019.