Cholestasis, ExtrahepaticNCT02103413
EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP
A study testing EUS-BD and PTBD in people with Cholestasis, Extrahepatic, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholestasis, Extrahepatic
- What is being tested?
- EUS-BD and PTBD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2014to Jun 2015
- 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
- Presence of unresectable malignant distal biliary obstruction (greater 2cm than distal to hilum, i.e., pancreatic cancer, common bile duct cancer, ampulla of Vater cancer, gallbladder cancer, duodenal cancer, and metastatic biliary obstruction)
- Failed conventional ERCP and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation.)
- Histologic or cytologic diagnosis of malignancy, d) A Karnofsky index of ≧30%, e) No serious or uncontrolled medical illness
- Provided informed consent.
Who cannot join
- patient age of less than 18 years
- uncorrectable coagulopathy
- history of allergy to radiocontrast agents
- refusal to participate in this study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multicenter Study of EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP
Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.
Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.
Read more
Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 There has been no comparative study between the outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.
The researchers investigated the technical success of EUS-BD and PTBD in patients with malignant biliary obstruction after failed conventional ERCP as a prospective randomized comparative study in multicenters. Secondary endpoints were the cost-effectiveness and complications rates between EUS-BD and PTBD.
- Conditions
- Cholestasis, Extrahepatic
- Being tested
- EUS-BD, PTBD
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-BDDevice
When the ERCP was unsuccessful, we tried one-step EUS-BDS using a linear-array echoendoscope (GF-UCT 240-AL 10 or AL 5, Olympus Medical Systems, Tokyo, Japan) at the same ERCP unit on the same session. EUS-BDS was performed by EUS-guided choledocoduodeostomy (EUS-CD) or EUS-guided hepaticogastrostomy (EUS-HG) at the discretion of involved endosonographers. Based on our modified protocol from two our proposed protocols, EUS-BD with transmural stenting was only considered.
PTBDDevice
PTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists.
| Study group | Role | What they receive |
|---|---|---|
| EUS-BD | Experimental | EUS-BD using a fully or partially covered self-expanding metallic stent will be performed by EUS guided 19 G needle puncture. Receives: Device: EUS-BD |
| PTBD | Experimental | PTBD with 8.5F catheter will be inserted under fluoroscopic and/or ultrasonography guidance by experienced interventional radiologists. Receives: Device: PTBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of EUS-BD and PTBD
Technical success rate of EUS-BD and PTBD after failed ERCP
Measured: twelve months
Secondary outcomes (1)
Complications of EUS-BD and PTBD
Complications rate of EUS-BD and PTBD in patients who failed ERCP
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestasis, ExtrahepaticStudies of the same condition, open and under way.
- More trials run by Asan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Hyun Park, Asan Medical Center
- Investigators
- Do Hyun Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103413
- Sponsor's protocol ID
- EUS-BD-002
- Status last verified
- Aug 2015
- First submitted
- 1 Apr 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of EUS-guided Biliary Drainage Versus Percutanenous Transhepatic Biliary Darinage for Malignant Biliary Obstruction After Failed ERCP
- ClinicalTrials.gov ID
- NCT02103413
- Acronym / sponsor ID
- EUS-BD-002
- Conditions
- Cholestasis, Extrahepatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Apr 2014 (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.
Although ERCP is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients.
Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery.
Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 There has been no comparative study between the outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.
The researchers investigated the technical success of EUS-BD and PTBD in patients with malignant biliary obstruction after failed conventional ERCP as a prospective randomized comparative study in multicenters. Secondary endpoints were the cost-effectiveness and complications rates between EUS-BD and PTBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-BD | Experimental | Device: EUS-BDEUS-BD using a fully or partially covered self-expanding metallic stent will be performed by EUS guided 19 G needle puncture. |
| PTBD | Experimental | Device: PTBDPTBD with 8.5F catheter will be inserted under fluoroscopic and/or ultrasonography guidance by experienced interventional radiologists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of unresectable malignant distal biliary obstruction (greater 2cm than distal to hilum, i.e., pancreatic cancer, common bile duct cancer, ampulla of Vater cancer, gallbladder cancer, duodenal cancer, and metastatic biliary obstruction)
- Failed conventional ERCP and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation.)
- Histologic or cytologic diagnosis of malignancy, d) A Karnofsky index of ≧30%, e) No serious or uncontrolled medical illness
- Provided informed consent.
Key exclusion criteria (4 listed)
- patient age of less than 18 years
- uncorrectable coagulopathy
- history of allergy to radiocontrast agents
- refusal to participate in this study.
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 |
|---|---|---|
| EUS-BDWhen the ERCP was unsuccessful, we tried one-step EUS-BDS using a linear-array echoendoscope (GF-UCT 240-AL 10 or AL 5, Olympus Medical Systems, Tokyo, Japan) at the same ERCP unit on the same session. EUS-BDS was performed by EUS-guided choledocoduodeostomy (EUS-CD) or EUS-guided hepaticogastrostomy (EUS-HG) at the discretion of involved endosonographers. Based on our modified protocol from two our proposed protocols, EUS-BD with transmural stenting was only considered. | Device | EUS-BD |
| PTBDPTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists. | Device | PTBD |
Primary outcome
Technical success of EUS-BD and PTBD
Time frame: twelve months
Technical success rate of EUS-BD and PTBD after failed ERCP
1 secondary outcome
Complications of EUS-BD and PTBD
Time frame: twelve months
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 7 Aug 2015.
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.
Do Hyun Park, MD, PhD principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-BD and PTBD in people with Cholestasis, Extrahepatic, run by Asan Medical Center at 2 sites in South Korea.
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 4 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 of EUS-BD and PTBD (time frame: twelve months). 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 7 Aug 2015.