The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
Primary Purpose
Biliary Stasis, Extrahepatic
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Stasis, Extrahepatic
Eligibility Criteria
Inclusion Criteria:
- Malignant distal bile duct obstruction
- Over 20 years old
- Techinical success of endoscopic retrograde biliary drainage with metalic stent
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Intervention : aspirin medication Case with aspirin medication for 6 months after stenting
Control : placebo medication Case with placebo medication for 6 months after stenting
Outcomes
Primary Outcome Measures
Incidence of stent dysfunction
Dysfunction after 6 months from stenting
Secondary Outcome Measures
Duration of metalic stent patency
Duration from insertion time to metallic stent dysfunction time
Incidence of further procedures
Incidence of further procedures needed for biliary drainage
Adverse events related with aspirin
Adverse events which clearly related with aspirin admistration including bleeding event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03279809
Brief Title
The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
Official Title
The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
One grade 4 adverse event (AE) and common (47.2%) grade 3 AEs
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
September 5, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Woo Hyun Paik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Stasis, Extrahepatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention : aspirin medication Case with aspirin medication for 6 months after stenting
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control : placebo medication Case with placebo medication for 6 months after stenting
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin 100 mg
Intervention Description
Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo drug of aspirin
Intervention Description
Case with placebo medication for 6 months after stenting
Primary Outcome Measure Information:
Title
Incidence of stent dysfunction
Description
Dysfunction after 6 months from stenting
Time Frame
6 months after biliary metalic stent
Secondary Outcome Measure Information:
Title
Duration of metalic stent patency
Description
Duration from insertion time to metallic stent dysfunction time
Time Frame
6 months after biliary metalic stent
Title
Incidence of further procedures
Description
Incidence of further procedures needed for biliary drainage
Time Frame
6 months after biliary metalic stent
Title
Adverse events related with aspirin
Description
Adverse events which clearly related with aspirin admistration including bleeding event
Time Frame
6 months after biliary metalic stent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Malignant distal bile duct obstruction
Over 20 years old
Techinical success of endoscopic retrograde biliary drainage with metalic stent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Hyun Paik, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32000828
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
We'll reach out to this number within 24 hrs