Malignant Distal Biliary ObstructionNCT01889953
EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
A study testing EUS-guided biliary drainage in people with Malignant Distal Biliary Obstruction, run by Johns Hopkins University at 13 sites in 5 countries.
Trial summary
This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Distal Biliary Obstruction
- What is being tested?
- EUS-guided biliary drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Dec 2012to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution's definition of "failed" procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at your institution can be considered as total of two failures.
- Ability to give informed consent
Who cannot join
- Unable to give informed consent
- Life expectancy < 1month
- Pregnant or breastfeeding women
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), or on chronic anticoagulation
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
Show all 9Show fewer
- Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
- ESLD with portal hypertension, varices, and/or ascites
- Liver metastases burden > 30%
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States7 sites
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Indiana University
Bloomington, Indiana, 47405
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Florida
Gainesville, Florida, 32607
Winthrop University Hospital
Mineola, New York, 11501
Florida Hospital
Orlando, Florida, 32803
India2 sites
All India Institute of Medical Sciences
Delhi, 110029
Institute of advanced endoscopy
Mumbai, 400036
Netherlands2 sites
Academic Medical Center of Amsterdam
Amsterdam, 1105
Erasmus Medical Center
Rotterdam, 3000
About this study
This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure.
Read the detailed description
Our central hypothesis is that EGBD is equally effective and safe to percutaneous transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP. Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study will be a prospective multicenter feasibility study that will include patients with inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated, our goal will be to compare EGBD and PTBD in a randomized multicenter international trial with a crossover design.
- Conditions
- Malignant Distal Biliary Obstruction
- Being tested
- EUS-guided biliary drainage
- Keywords
- EUS-Guided Biliary Drainage, Endoscopic retrograde cholangiopancreatography, Malignant Biliary Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided biliary drainageOther
Based on the patient's condition, the will receive:
- Rendezvous technique
- Direct transluminal access transesophageal technique
- Direct transluminal access transduodenal technique
- or direct transluminal access using transgastric approach
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided biliary drainage | Other | Patients in this arm will receive EUS-guided biliary drainage. Receives: Other: EUS-guided biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level
Measured: From date of intervention up to 4 weeks
Secondary outcomes (6)
Quality of life (QOL)
Determine improvement in QOL of patients after PTBD. QOL will be assessed using the EORTC-QLQ-30 instrument (at baseline, 1 week, 4 weeks and 12 weeks after the procedure).
Measured: From date of intervention up to 12 weeks
Procedure-related costs
Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of PTBD in case of failed EGBD, cost of managing complications, cost of reintervention in case of stent occlusion, etc)
Measured: Lifetime (These patients have a life expectancy of less than 2 years)
Number of required procedures
Measured: From date of intervention up to death (These patients have a life expectancy of less than 2 years)
Technical success
This is defined as success of stent placement in the desired location as determined endoscopically and radiographically.
In addition, success of each step during EUS will be tracked and recorded (e.g. needle puncture, cholangiography, tract dilation, etc
Measured: Intra- and post intervention (These patients have a life expectancy of less than 2 years)
Stent patency
Determine stent patency which is defined as time period between stent placement and need for reintervention for signs and symptoms of recurrent biliary obstruction
Measured: Lifetime (These patients have a life expectancy of less than 2 years)
Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)
Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis
Measured: Lifetime (These patients have a life expectancy of less than 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Distal Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Colorado, Denver, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), All India Institute of Medical Sciences, Winthrop University Hospital, University of Florida, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Erasmus Medical Center, AdventHealth, Medical University of South Carolina, Institute of advanced endoscopy, Aichi Cancer Center
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen A Khashab, MD, Principal investigator, Johns Hopkins Hospital Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889953
- Sponsor's protocol ID
- NA_00077483
- Status last verified
- Jan 2015
- First submitted
- 4 Dec 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khashab MA, Van der Merwe S, Kunda R, El Zein MH, Teoh AY, Marson FP, Fabbri C, Tarantino I, Varadarajulu S, Modayil RJ, Stavropoulos SN, Penas I, Ngamruengphong S, Kumbhari V, Romagnuolo J, Shah R, Kalloo AN, Perez-Miranda M, Artifon EL. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30.
PubMed 27092334
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
- ClinicalTrials.gov ID
- NCT01889953
- Acronym / sponsor ID
- NA_00077483
- Conditions
- Malignant Distal Biliary Obstruction
- Keywords
- EUS-Guided Biliary Drainage, Endoscopic retrograde cholangiopancreatography, Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Indiana University, University of Colorado, Denver, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), All India Institute of Medical Sciences, Winthrop University Hospital, University of Florida, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Erasmus Medical Center, AdventHealth, Medical University of South Carolina, Institute of advanced endoscopy, Aichi Cancer Center
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Jul 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.
This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure.
Detailed description
Our central hypothesis is that EGBD is equally effective and safe to percutaneous transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP. Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study will be a prospective multicenter feasibility study that will include patients with inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated, our goal will be to compare EGBD and PTBD in a randomized multicenter international trial with a crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-guided biliary drainage | Other | Other: EUS-guided biliary drainagePatients in this arm will receive EUS-guided biliary drainage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution's definition of "failed" procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at your institution can be considered as total of two failures.
- Ability to give informed consent
Key exclusion criteria (9 listed)
- Unable to give informed consent
- Life expectancy < 1month
- Pregnant or breastfeeding women
- Acute gastrointestinal bleeding
- Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), or on chronic anticoagulation
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-guided biliary drainageBased on the patient's condition, the will receive: * Rendezvous technique * Direct transluminal access transesophageal technique * Direct transluminal access transduodenal technique * or direct transluminal access using transgastric approach | Other | EUS-guided biliary drainage |
Primary outcome
Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
Time frame: From date of intervention up to 4 weeks
Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level
6 secondary outcomes
Quality of life (QOL)
Time frame: From date of intervention up to 12 weeks
Procedure-related costs
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
Number of required procedures
Time frame: From date of intervention up to death (These patients have a life expectancy of less than 2 years)
Technical success
Time frame: Intra- and post intervention (These patients have a life expectancy of less than 2 years)
Stent patency
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)
Time frame: Lifetime (These patients have a life expectancy of less than 2 years)
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 25 May 2015.
- Derived from this study: PubMed 27092334Khashab MA, Van der Merwe S, Kunda R, El Zein MH, Teoh AY, Marson FP, Fabbri C, Tarantino I, Varadarajulu S, Modayil RJ, Stavropoulos SN, Penas I, Ngamruengphong S, Kumbhari V, Romagnuolo J, Shah R, Kalloo AN, Perez-Miranda M, Artifon EL. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30.
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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.
Mouen A Khashab, MD principal investigator
Johns Hopkins Hospital Department of Gastroenterology
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided biliary drainage in people with Malignant Distal Biliary Obstruction, run by Johns Hopkins University at 13 sites in 5 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 2 inclusion and 9 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, India, Netherlands, Italy, Japan. 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?
Effectiveness (Clinical success is defined as drop in bilirubin by 50%) (time frame: From date of intervention up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889953, which also lists 1 linked publication.
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 25 May 2015.