Malignant Biliary ObstructionB-GOODNCT05142839
Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.
A study testing EUS-CD and EUS-GEA in people with Malignant Biliary Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs). Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary… 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-CD and EUS-GEA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2021to 30 Sep 2022
- 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
- patients undergoing affected by distal malignant biliari obstruction and gastric outflow obstruction undergone EUS-CD and EUS-GEA or enteral stenting drainage between January 2016 to September 2021
Who cannot join
- Age under 18
- Enteral stenting or EUS-GEA performed before EUS-CD
- Provide an estimate of number of records you plan to review and time period that it will be covered.January 2016 to September 2021
- If the number of records you plan to exceeds 500, please provide the following:
- N/A
- Provide an estimate of how long it will take you to complete the study, including the time for data analysis.
- 3 month for data collection and 3 weeks for data analysis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Repici, MD, 0039-02-82247493, alessandro.repici@humanitas.it
About this study
Official title: Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. A Retrospective, Multicenter Study. (B-GOOD Study).
EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs).
Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events.
Read more
When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required.
Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging.
To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months.
However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present.
The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- EUS-CD, EUS-GEA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-CDProcedure or surgery
EUS-guided choledochoduodenostomy
EUS-GEAProcedure or surgery
EUS-guided gastroenterostomy
| Study group | Role | What they receive |
|---|---|---|
| EUS-CD | Experimental | EUS-guided choledochoduodenostomy Receives: Procedure: EUS-CD |
| EUS-GEA | Experimental | EUS-guided gastroenterostomy Receives: Procedure: EUS-GEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success for EUS-CD
Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks
Measured: 6 Months
Clinical success for EUS-GEA and enteral stenting
resolution of symptoms of GOO, with improvement in enteral diet assumption (creamy or solid) comparing to the baseline
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Dec 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142839
- Sponsor's protocol ID
- 12
- Acronym
- B-GOOD
- Status last verified
- Feb 2022
- First submitted
- 22 Nov 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. A Retrospective, Multicenter Study. (B-GOOD Study).
- ClinicalTrials.gov ID
- NCT05142839
- Acronym / sponsor ID
- B-GOOD / 12
- Conditions
- Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 3 Dec 2021 (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.
EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs).
Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events.
When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required.
Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging.
To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months.
However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present.
The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-CD | Experimental | Procedure: EUS-CDEUS-guided choledochoduodenostomy |
| EUS-GEA | Experimental | Procedure: EUS-GEAEUS-guided gastroenterostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing affected by distal malignant biliari obstruction and gastric outflow obstruction undergone EUS-CD and EUS-GEA or enteral stenting drainage between January 2016 to September 2021
Key exclusion criteria (7 listed)
- Age under 18
- Enteral stenting or EUS-GEA performed before EUS-CD
- Provide an estimate of number of records you plan to review and time period that it will be covered.January 2016 to September 2021
- If the number of records you plan to exceeds 500, please provide the following:
- N/A
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-CDEUS-guided choledochoduodenostomy | Procedure or surgery | EUS-CD |
| EUS-GEAEUS-guided gastroenterostomy | Procedure or surgery | EUS-GEA |
Primary outcome
Clinical success for EUS-CD
Time frame: 6 Months
Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks
Clinical success for EUS-GEA and enteral stenting
Time frame: 6 Months
resolution of symptoms of GOO, with improvement in enteral diet assumption (creamy or solid) comparing to the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-CD and EUS-GEA in people with Malignant Biliary Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Anderloni, MD (0039-02-82247308, andrea.anderloni@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success for EUS-CD (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 22 Feb 2022.