Malignant Biliary ObstructionPhase 2/3DRAMBONCT03000855
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures
A Phase 2/3 study testing EUS-guided choledocho-duodenostomy and Endoscopic retrograde cholangiopancreatography with covered metallic stent in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 6 sites in 5 countries.
Trial summary
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- EUS-guided choledocho-duodenostomy and Endoscopic retrograde cholangiopancreatography with covered metallic stent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Dec 2016to Dec 2022
- Phase
- Phase 2/3
- 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 years old with informed consent
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
- Distal tumors 2cm away from the portal hilum
- Bilirubin > 50umol/L at diagnosis
Who cannot join
- Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
- Presence of main portal vein thrombosis
- Prior SEMS placement
- Intraductal papillary mucinous carcinomas
- Prior Billroth II or roux-en Y reconstruction
- History of bleeding disorder or use of anticoagulation
Show all 11Show fewer
- Child's B/C cirrhosis
- Pregnancy
- Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
- Presence of other malignancy
- Life expectancy < 3months
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Japan2 sites
Tokyo Medical University Hospital
Tokyo
Wakayama Medical University School of Medicine
Wakayama
About this study
Official title: EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures. A Multi-centred Randomised Controlled Trial
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain.
The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
Read the detailed description
Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. Malignant biliary obstruction is traditionally palliated with ERCP with metallic stent insertion. However, these stents are prone to obstruction due to tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required.
Recently, ECDS has been described as an alternative to percutaneous biliary drainage in patients with failed ERCP. The procedure is also associated with potential advantages as compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- EUS-guided choledocho-duodenostomy, Endoscopic retrograde cholangiopancreatography with covered metallic stent
- Keywords
- Malignant biliary obstruction, EUS - guided choledocho-duodenostomy, ERCP with covered metallic stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided choledocho-duodenostomyProcedure or surgery
The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025" or 0.035" guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation.
Endoscopic retrograde cholangiopancreatography with covered metallic stentProcedure or surgery
After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.
| Study group | Role | What they receive |
|---|---|---|
| ECDS | Active comparator | EUS-guided choledocho-duodenostomy Receives: Procedure: EUS-guided choledocho-duodenostomy |
| ERCP with CSEMS | Active comparator | Endoscopic retrograde cholangiopancreatography with covered metallic stent Receives: Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent patency rate
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
Measured: 1-year
Secondary outcomes (3)
Technical success
Technical success is defined as the ability to access and drain the CBD by placement of a stent.
Measured: 1year
Clinical success
Clinical success is defined as >30% drop in bilirubin levels
Measured: 1 year
Adverse events
Adverse events related to the endoscopic procedures would be graded according to the lexicon of endoscopic adverse events
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 posted22 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2021
- Study completionDec 2022
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 Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo Medical University, Kinki University
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
- Investigators
- Anthony Teoh, FRCSEd(Gen, Principal investigator, anthoyteoh@surgery.cuhk.edu.hk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000855
- Sponsor's protocol ID
- CRE-2016.193-T
- Acronym
- DRAMBO
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2016
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.
PubMed 37121331
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures. A Multi-centred Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03000855
- Acronym / sponsor ID
- DRAMBO / CRE-2016.193-T
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant biliary obstruction, EUS - guided choledocho-duodenostomy, ERCP with covered metallic stents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Tokyo Medical University, Kinki University
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 22 Dec 2016 (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.
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain.
The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
Detailed description
Malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. Malignant biliary obstruction is traditionally palliated with ERCP with metallic stent insertion. However, these stents are prone to obstruction due to tumour ingrowth. In addition, ERCP may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required.
Recently, ECDS has been described as an alternative to percutaneous biliary drainage in patients with failed ERCP. The procedure is also associated with potential advantages as compared to conventional ERCP. In particular, the risk of tumour ingrowth into the stent placed after ECDS is low and stent patency rates may be better than ERCP. Thus, the aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECDS | Active comparator | Procedure: EUS-guided choledocho-duodenostomyEUS-guided choledocho-duodenostomy |
| ERCP with CSEMS | Active comparator | Procedure: Endoscopic retrograde cholangiopancreatography with covered metallic stentEndoscopic retrograde cholangiopancreatography with covered metallic stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old with informed consent
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
- Distal tumors 2cm away from the portal hilum
- Bilirubin > 50umol/L at diagnosis
Key exclusion criteria (11 listed)
- Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
- Presence of main portal vein thrombosis
- Prior SEMS placement
- Intraductal papillary mucinous carcinomas
- Prior Billroth II or roux-en Y reconstruction
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 choledocho-duodenostomyThe CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025" or 0.035" guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation. | Procedure or surgery | ECDS |
| Endoscopic retrograde cholangiopancreatography with covered metallic stentAfter cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment. | Procedure or surgery | ERCP with CSEMS |
Primary outcome
stent patency rate
Time frame: 1-year
Stent dysfunction is defined as radiology or endoscopy confirmed stent obstruction.
3 secondary outcomes
Technical success
Time frame: 1year
Clinical success
Time frame: 1 year
Adverse events
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 31 Aug 2023.
- Derived from this study: PubMed 37121331Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.
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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.
Anthony Teoh, FRCSEd(Gen principal investigator
anthoyteoh@surgery.cuhk.edu.hk
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EUS-guided choledocho-duodenostomy and Endoscopic retrograde cholangiopancreatography with covered metallic stent in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 6 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 5 inclusion and 11 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, Australia, Belgium, China, Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
stent patency rate (time frame: 1-year). 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 NCT03000855, 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 31 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.