Plastic Stent OcclusionNCT03849859
Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction
A study testing Single plastic stent and Multiple plastic stents in people with Plastic Stent Occlusion, run by Prince of Songkla University at 2 sites in Thailand.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plastic Stent Occlusion
- What is being tested?
- Single plastic stent and Multiple plastic stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesThailand
- Study dates
- 1 May 2019to 30 Nov 2020
- 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
- In-operable distal malignant bile duct obstruction Age>18
Who cannot join
- Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.
Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.
Read the detailed description
The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.
- Conditions
- Plastic Stent Occlusion
- Being tested
- Single plastic stent, Multiple plastic stents
- Keywords
- Plastic stent, Endoscopic Retrograde Cholangiopancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single plastic stentDevice
Deployment of single plastic stent
Multiple plastic stentsDevice
Deployment of multiple plastic stents
| Study group | Role | What they receive |
|---|---|---|
| Single plastic stent | Active comparator | Deployment of single plastic stent Receives: Device: Single plastic stent |
| Multiple plastic stents | Active comparator | Deployment of multiple plastic stent Receives: Device: Multiple plastic stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative stent patency
Proportion of patients with documented stent dysfunction
Measured: From the date of randomization though the study completion, assessed up to 1 year.
Clinical success rate
Proportion of patients with total bilirubin level declining > 50 % of the initial value
Measured: Four weeks after randomization
Secondary outcomes (4)
Overall adverse events
Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.
Measured: From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Overall patient survival
Proportion of patients who die from any causes.
Measured: From the date of randomization until the date of death from any cause, assessed up to 12 months.
Procedure relate death
Proportion of patients who die from complications related procedure.
Measured: From the date of randomization until the date of death from procedure within 7 days
Technical success rate
Proportion of patient who successful underwent stent placement.
Measured: From the date of randomization until the last stent deploy, assessed up to 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion30 Nov 2020
Why it stopped: The study was terminated because of difficulty in completing the study as originally planned and loss of extra-funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plastic Stent OcclusionStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Ni Netinatsunton, M.D., Principal investigator, NKC Institute of Gastroenterology and Hepatology.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849859
- Sponsor's protocol ID
- REC.61-096-21-1
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.
- ClinicalTrials.gov ID
- NCT03849859
- Acronym / sponsor ID
- REC.61-096-21-1
- Conditions
- Plastic Stent Occlusion
- Keywords
- Plastic stent, Endoscopic Retrograde Cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of difficulty in completing the study as originally planned and loss of extra-funding.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Feb 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.
Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.
Detailed description
The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single plastic stent | Active comparator | Device: Single plastic stentDeployment of single plastic stent |
| Multiple plastic stents | Active comparator | Device: Multiple plastic stentsDeployment of multiple plastic stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-operable distal malignant bile duct obstruction Age>18
Key exclusion criteria (1 listed)
- Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
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 |
|---|---|---|
| Single plastic stentDeployment of single plastic stent | Device | Single plastic stent |
| Multiple plastic stentsDeployment of multiple plastic stents | Device | Multiple plastic stents |
Primary outcome
Cumulative stent patency
Time frame: From the date of randomization though the study completion, assessed up to 1 year.
Proportion of patients with documented stent dysfunction
Clinical success rate
Time frame: Four weeks after randomization
Proportion of patients with total bilirubin level declining > 50 % of the initial value
4 secondary outcomes
Overall adverse events
Time frame: From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Overall patient survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 12 months.
Procedure relate death
Time frame: From the date of randomization until the date of death from procedure within 7 days
Technical success rate
Time frame: From the date of randomization until the last stent deploy, assessed up to 1 day.
Results and safety
The study was stopped early (reason given: The study was terminated because of difficulty in completing the study as originally planned and loss of extra-funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
Ni Netinatsunton, M.D. principal investigator
NKC Institute of Gastroenterology and Hepatology.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single plastic stent and Multiple plastic stents in people with Plastic Stent Occlusion, run by Prince of Songkla University at 2 sites in Thailand.
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 1 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: stopped early, as of the sponsor's last update on 1 Apr 2021. 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 Thailand. 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 was stopped early (reason given: The study was terminated because of difficulty in completing the study as originally planned and loss of extra-funding.). Results are not available in the source record.
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?
Cumulative stent patency (time frame: From the date of randomization though the study completion, assessed up to 1 year.). 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 1 Apr 2021.