Malignant Biliary ObstructionNCT03812250
EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction
A study testing ERCP assisted trans-papillary drainage for malignant biliary obstruction and EUS-guide biliary drainage for malignant biliary obstruction in people with Malignant Biliary Obstruction, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- ERCP assisted trans-papillary drainage for malignant biliary obstruction and EUS-guide biliary drainage for malignant biliary obstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 15 Feb 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18 - 85 years
- a patients who had malignant biliary obstruction confirmed by imaging examinations and Pathological examination
- Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl)
- inoperable state
- patients who agree to join this study
Who cannot join
- a patients who cannot endure sedation or therapeutic endoscopic procedure
- a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000)
- patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic biliary drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction.
Subjects of the study: Patients who have malignant biliary obstruction.
Read more
Methods of the study:
- Prospective randomized controlled study
- Patients were randomly divided into two groups, EUS-BD group or ERCP group
- Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction
- After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate.
Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
Read the detailed description
ERCP is a well-established procedure for the management of malignant biliary obstruction. However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive options are usually considered, which including percutaneous trans-hepatic biliary drainage and surgical intervention, but they all have been associated with a higher risk of complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent, particularly a lumen-apposing metal stent, is a promising technique for biliary decompression in patients with failed ERCP. There has been growing global experience with EUS-BD in recent years, and data from expert centers support the feasibility and efficacy of EUS-BD. However, few researches compared the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction. The investigators herein aim to conduct a randomized controlled clinical trial to compare the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- ERCP assisted trans-papillary drainage for malignant biliary obstruction, EUS-guide biliary drainage for malignant biliary obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP assisted trans-papillary drainage for malignant biliary obstructionProcedure or surgery
ERCP assisted trans-papillary drainage for malignant biliary obstruction
EUS-guide biliary drainage for malignant biliary obstructionProcedure or surgery
EUS-guide biliary drainage for malignant biliary obstruction
| Study group | Role | What they receive |
|---|---|---|
| ERCP assisted trans-papillary drainage | Active comparator | ERCP assisted trans-papillary drainage for malignant biliary obstruction Receives: Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction |
| EUS-guide biliary drainage | Active comparator | EUS-guide biliary drainage for malignant biliary obstruction Receives: Procedure: EUS-guide biliary drainage for malignant biliary obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rates
The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.
Measured: one month after the procedures.
Adverse events rates
The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.
Measured: within 6-9 months after the procedures
Secondary outcomes (3)
Re-intervention rates
Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)
Measured: within 6-9 months from the procedures
Evaluation of the cost of the procedure and hospitalization.
Evaluation of the cost for different procedures.
Measured: Up to 30 days after the intervention.
overall survival
death in the follow up after endoscopic treatment
Measured: within 6-9 months from the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2019
- Primary completion10 Feb 2023
- Study completion15 Feb 2023
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.
- 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, M.D., Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812250
- Sponsor's protocol ID
- 2018
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.
PubMed 29605722
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03812250
- Acronym / sponsor ID
- 2018
- Conditions
- Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 23 Jan 2019 (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.
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction.
Subjects of the study: Patients who have malignant biliary obstruction.
Methods of the study:
- Prospective randomized controlled study
- Patients were randomly divided into two groups, EUS-BD group or ERCP group
- Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction
- After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate.
Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
Detailed description
ERCP is a well-established procedure for the management of malignant biliary obstruction. However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive options are usually considered, which including percutaneous trans-hepatic biliary drainage and surgical intervention, but they all have been associated with a higher risk of complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent, particularly a lumen-apposing metal stent, is a promising technique for biliary decompression in patients with failed ERCP. There has been growing global experience with EUS-BD in recent years, and data from expert centers support the feasibility and efficacy of EUS-BD. However, few researches compared the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction. The investigators herein aim to conduct a randomized controlled clinical trial to compare the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP assisted trans-papillary drainage | Active comparator | Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstructionERCP assisted trans-papillary drainage for malignant biliary obstruction |
| EUS-guide biliary drainage | Active comparator | Procedure: EUS-guide biliary drainage for malignant biliary obstructionEUS-guide biliary drainage for malignant biliary obstruction |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age: 18 - 85 years
- a patients who had malignant biliary obstruction confirmed by imaging examinations and Pathological examination
- Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl)
- inoperable state
- patients who agree to join this study
Key exclusion criteria (3 listed)
- a patients who cannot endure sedation or therapeutic endoscopic procedure
- a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000)
- patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic biliary drainage
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 |
|---|---|---|
| ERCP assisted trans-papillary drainage for malignant biliary obstructionERCP assisted trans-papillary drainage for malignant biliary obstruction | Procedure or surgery | ERCP assisted trans-papillary drainage |
| EUS-guide biliary drainage for malignant biliary obstructionEUS-guide biliary drainage for malignant biliary obstruction | Procedure or surgery | EUS-guide biliary drainage |
Primary outcome
Clinical success rates
Time frame: one month after the procedures.
The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.
Adverse events rates
Time frame: within 6-9 months after the procedures
The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.
3 secondary outcomes
Re-intervention rates
Time frame: within 6-9 months from the procedures
Evaluation of the cost of the procedure and hospitalization.
Time frame: Up to 30 days after the intervention.
overall survival
Time frame: within 6-9 months from the procedures
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 21 Feb 2023.
- Results publication: PubMed 29605722Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 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.
Xiaofeng Zhang, M.D. principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP assisted trans-papillary drainage for malignant biliary obstruction and EUS-guide biliary drainage for malignant biliary obstruction in people with Malignant Biliary Obstruction, run by First People's Hospital of Hangzhou at 1 site in China.
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 3 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 21 Feb 2023. 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 China. 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?
Clinical success rates (time frame: one month after the procedures.). 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?
On the ClinicalTrials.gov record for NCT03812250, 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 21 Feb 2023.