JaundiceNCT01499537
Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct
A study testing biliary drainage and EUS guided biliary drainage in people with Jaundice, run by Institut Paoli-Calmettes at 3 sites in 2 countries.
Trial summary
At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaundice
- What is being tested?
- biliary drainage and EUS guided biliary drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2011to Mar 2016
- 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
- age >= 18
- Karnofsky >= 50%
- biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
- signed informed consent
Who cannot join
- isolated biliary stenosis of right hepatic canal
- percutaneous biliary drainage < 10 days
- laparotomy < 10 days
- contra-indication to the procedure
- pregnant women
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Institut Paoli-Calmettes
Marseille, 13009
Hopital Nord
Marseille, 13020
About this study
Official title: Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct in Patients With Malignant or Post-operative Jaundice After Failure or Impossibility to Perform Endoscopic Retrograde Cholangiography
At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.
- Conditions
- Jaundice
- Being tested
- biliary drainage, EUS guided biliary drainage
- Keywords
- Stenosis of biliary ways
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary drainageDevice
percutaneous transhepatic biliary drainage (PTBD)
EUS guided biliary drainageDevice
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Drainage | Active comparator | Percutaneous Transhepatic Biliary Drainage (PTBD) Receives: Device: biliary drainage |
| EUS-guided drainage | Experimental | endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall Receives: Device: EUS guided biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity rate
Morbidity rate during 30 post-operative days
Measured: 30 days
Secondary outcomes (4)
efficacy
decrease of bilirubine > 50%
Measured: 15 days
feasibility
succes or not of the intervention to obtain bilairy drainage
Measured: up to 3 days
biliary drainage duration
time between intervention and drain withdrawal
Measured: up to 1 month
quality of life
QLQ-C30 questionnary at inclusion and at D30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan BORIES, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499537
- Sponsor's protocol ID
- APHAGE/IPC 2010-002
- Status last verified
- Feb 2016
- First submitted
- 16 Sep 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct in Patients With Malignant or Post-operative Jaundice After Failure or Impossibility to Perform Endoscopic Retrograde Cholangiography
- ClinicalTrials.gov ID
- NCT01499537
- Acronym / sponsor ID
- APHAGE/IPC 2010-002
- Conditions
- Jaundice
- Keywords
- Stenosis of biliary ways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Dec 2011 (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.
At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Drainage | Active comparator | Device: biliary drainagePercutaneous Transhepatic Biliary Drainage (PTBD) |
| EUS-guided drainage | Experimental | Device: EUS guided biliary drainageendoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >= 18
- Karnofsky >= 50%
- biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
- signed informed consent
Key exclusion criteria (5 listed)
- isolated biliary stenosis of right hepatic canal
- percutaneous biliary drainage < 10 days
- laparotomy < 10 days
- contra-indication to the procedure
- pregnant women
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 |
|---|---|---|
| biliary drainagepercutaneous transhepatic biliary drainage (PTBD) | Device | Percutaneous Drainage |
| EUS guided biliary drainageendoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall | Device | EUS-guided drainage |
Primary outcome
Morbidity rate
Time frame: 30 days
Morbidity rate during 30 post-operative days
4 secondary outcomes
efficacy
Time frame: 15 days
feasibility
Time frame: up to 3 days
biliary drainage duration
Time frame: up to 1 month
quality of life
Time frame: 30 days
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 19 May 2016.
- sponsor web siteLink provided by the sponsor.
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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.
Erwan BORIES, MD principal investigator
Institut Paoli-Calmettes
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biliary drainage and EUS guided biliary drainage in people with Jaundice, run by Institut Paoli-Calmettes at 3 sites in 2 countries.
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 4 inclusion and 5 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Monaco. 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?
Morbidity rate (time frame: 30 days). 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 19 May 2016.