Biliary Stasis, ExtrahepaticNCT03279809
The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
A study testing Aspirin in people with Biliary Stasis, Extrahepatic, run by Woo Hyun Paik at 1 site in South Korea.
Trial summary
The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered and its maintenance period has been… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Stasis, Extrahepatic
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2017to 5 Sep 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant distal bile duct obstruction
- Over 20 years old
- Techinical success of endoscopic retrograde biliary drainage with metalic stent
Who cannot join
- Patient's denial
- Previous Aspirin use
- Aspirin allergy
- Contraindication for aspirin
- Life expectancy < 6mo
- Gastroduodenal ulcer
- History of substance abuse
- Participation in a clinical trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 110-744
About this study
The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered and its maintenance period has been reported to be about 8 months. This study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6 months after the procedure. The secondary endpoints included duration of metallic stent patency, incidence of further procedures, and adverse events related with aspirin.
Read the detailed description
Background -Endoscopic drainage is the first choice for bile drainage in patients with malignant distal biliary obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered. Metal stents have proven superior in many clinical aspects over plastic stents. Nonetheless, the maintenance period of the metallic stent patency has been reported to be around 8 months, and it is often necessary to undergo further procedure due to dysfunction of stents. Recently, it has been reported that the duration of the metallic stent patency in patients with aspirin is prolonged. Since the previous study was a retrospective study, this study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The incidence of stent dysfunction in both groups for 6 months after the procedure will be compared. Stent dysfunction is defined as any case which further procedure is required due to jaundice or cholangitis after stent insertion.
Study aim
-The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction.
Data analysis
- Blinding will remain in place until the statistician codes the statistical analyses of the primary and secondary outcomes. The statistical analyses will be done using the full analysis set according to the intention-to-treat principle, meaning all the randomized patients will be analyzed in their allocated groups regardless of any protocol violations or early treatment discontinuations. The outcomes through a per-protocol analysis set that will consider only the subjects who followed the protocol effectively will be analyzed.
- The rate of stent dysfunction will be compared using Pearson's chi-squared test with Fisher's exact test and calculated the odds ratio of the event. The secondary outcomes (i.e., the duration of stent patency, the rate of reintervention, and the adverse events related to aspirin administration) will be analyzed using Pearson's chi-squared test with Fisher's exact test, Student's t-test, and Kaplan-Meier curves stratified by drug and the hazard ratios between two groups using the Cox proportional hazards. The further affecting factors for stent dysfunction will be assessed by univariable and multivariable logistic regression analysis.
- In the initial plan, it was decided not to perform interim analysis, but it was confirmed that more adverse events occurred than expected in the process of conducting the study. Therefore, the interim analysis was performed with the data up to May 2020, and determine whether to continue the study by measuring the benefits and losses obtained from aspirin.
- Conditions
- Biliary Stasis, Extrahepatic
- Being tested
- Aspirin, Placebo
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Aspirin 100 mg
Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction
PlaceboDrug
Also called Placebo drug of aspirin
Case with placebo medication for 6 months after stenting
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention : aspirin medication Case with aspirin medication for 6 months after stenting Receives: Drug: Aspirin |
| Control | Placebo comparator | Control : placebo medication Case with placebo medication for 6 months after stenting Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stent dysfunction
Dysfunction after 6 months from stenting
Measured: 6 months after biliary metalic stent
Secondary outcomes (3)
Duration of metalic stent patency
Duration from insertion time to metallic stent dysfunction time
Measured: 6 months after biliary metalic stent
Incidence of further procedures
Incidence of further procedures needed for biliary drainage
Measured: 6 months after biliary metalic stent
Adverse events related with aspirin
Adverse events which clearly related with aspirin admistration including bleeding event
Measured: 6 months after biliary metalic stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start12 Oct 2017
- Primary completion5 Sep 2020
- Study completion5 Sep 2020
Why it stopped: One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs
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 Biliary Stasis, ExtrahepaticStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woo Hyun Paik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Woo Hyun Paik, Seoul National University Hospital
- Investigators
- Woo Hyun Paik, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279809
- Sponsor's protocol ID
- H-1707-161-874
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi JH, Paik WH, You MS, Lee KJ, Choi YH, Shin BS, Lee SH, Ryu JK, Kim YT. Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial. Trials. 2020 Jan 30;21(1):120. doi: 10.1186/s13063-020-4083-z.
PubMed 32000828
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT03279809
- Acronym / sponsor ID
- H-1707-161-874
- Conditions
- Biliary Stasis, Extrahepatic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Woo Hyun PaikUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 12 Sep 2017 (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.
The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered and its maintenance period has been reported to be about 8 months. This study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The primary endpoint is the incidence of stent dysfunction in both groups for 6 months after the procedure. The secondary endpoints included duration of metallic stent patency, incidence of further procedures, and adverse events related with aspirin.
Detailed description
Background -Endoscopic drainage is the first choice for bile drainage in patients with malignant distal biliary obstruction. Metal stents are mainly used for malignant biliary obstruction if the surgical treatment is not considered. Metal stents have proven superior in many clinical aspects over plastic stents. Nonetheless, the maintenance period of the metallic stent patency has been reported to be around 8 months, and it is often necessary to undergo further procedure due to dysfunction of stents. Recently, it has been reported that the duration of the metallic stent patency in patients with aspirin is prolonged. Since the previous study was a retrospective study, this study will be prospectively conducted as a randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. The incidence of stent dysfunction in both groups for 6 months after the procedure will be compared. Stent dysfunction is defined as any case which further procedure is required due to jaundice or cholangitis after stent insertion.
Study aim
-The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction.
Data analysis
- Blinding will remain in place until the statistician codes the statistical analyses of the primary and secondary outcomes. The statistical analyses will be done using the full analysis set according to the intention-to-treat principle, meaning all the randomized patients will be analyzed in their allocated groups regardless of any protocol violations or early treatment discontinuations. The outcomes through a per-protocol analysis set that will consider only the subjects who followed the protocol effectively will be analyzed.
- The rate of stent dysfunction will be compared using Pearson's chi-squared test with Fisher's exact test and calculated the odds ratio of the event. The secondary outcomes (i.e., the duration of stent patency, the rate of reintervention, and the adverse events related to aspirin administration) will be analyzed using Pearson's chi-squared test with Fisher's exact test, Student's t-test, and Kaplan-Meier curves stratified by drug and the hazard ratios between two groups using the Cox proportional hazards. The further affecting factors for stent dysfunction will be assessed by univariable and multivariable logistic regression analysis.
- In the initial plan, it was decided not to perform interim analysis, but it was confirmed that more adverse events occurred than expected in the process of conducting the study. Therefore, the interim analysis was performed with the data up to May 2020, and determine whether to continue the study by measuring the benefits and losses obtained from aspirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: AspirinIntervention : aspirin medication Case with aspirin medication for 6 months after stenting |
| Control | Placebo comparator | Drug: PlaceboControl : placebo medication Case with placebo medication for 6 months after stenting |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Malignant distal bile duct obstruction
- Over 20 years old
- Techinical success of endoscopic retrograde biliary drainage with metalic stent
Key exclusion criteria (8 listed)
- Patient's denial
- Previous Aspirin use
- Aspirin allergy
- Contraindication for aspirin
- Life expectancy < 6mo
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 |
|---|---|---|
| AspirinAlso: Aspirin 100 mgAspirin medication (100mg daily) after biliary stent insertion for malignant obstruction | Drug | Intervention |
| PlaceboAlso: Placebo drug of aspirinCase with placebo medication for 6 months after stenting | Drug | Control |
Primary outcome
Incidence of stent dysfunction
Time frame: 6 months after biliary metalic stent
Dysfunction after 6 months from stenting
3 secondary outcomes
Duration of metalic stent patency
Time frame: 6 months after biliary metalic stent
Incidence of further procedures
Time frame: 6 months after biliary metalic stent
Adverse events related with aspirin
Time frame: 6 months after biliary metalic stent
Results and safety
The study was stopped early (reason given: One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 32000828Choi JH, Paik WH, You MS, Lee KJ, Choi YH, Shin BS, Lee SH, Ryu JK, Kim YT. Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial. Trials. 2020 Jan 30;21(1):120. doi: 10.1186/s13063-020-4083-z.
- Individual participant dataSharing planned: Undecided
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.
Woo Hyun Paik, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin in people with Biliary Stasis, Extrahepatic, run by Woo Hyun Paik at 1 site in South Korea.
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 3 inclusion and 8 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 17 Mar 2021. 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 South Korea. 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. Some participants in this study may receive a placebo. 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: One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs). 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?
Incidence of stent dysfunction (time frame: 6 months after biliary metalic stent). 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 NCT03279809, 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 17 Mar 2021.