NCT03279809

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

September 5, 2017

Last Update Submit

March 15, 2021

Conditions

Biliary Stasis, Extrahepatic

Outcome Measures

Primary Outcomes (1)

  • Incidence of stent dysfunction

    Dysfunction after 6 months from stenting

    6 months after biliary metalic stent

Secondary Outcomes (3)

  • Duration of metalic stent patency

    6 months after biliary metalic stent

  • Incidence of further procedures

    6 months after biliary metalic stent

  • Adverse events related with aspirin

    6 months after biliary metalic stent

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention : aspirin medication Case with aspirin medication for 6 months after stenting

Drug: Aspirin

Control

PLACEBO COMPARATOR

Control : placebo medication Case with placebo medication for 6 months after stenting

Drug: Placebo

Interventions

AspirinDRUG

Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction

Also known as: Aspirin 100 mg
Intervention
PlaceboDRUG

Case with placebo medication for 6 months after stenting

Also known as: Placebo drug of aspirin
Control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant distal bile duct obstruction
  • Over 20 years old
  • Techinical success of endoscopic retrograde biliary drainage with metalic stent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32000828DERIVED

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Woo Hyun Paik, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 12, 2017

Study Start

October 12, 2017

Primary Completion

September 5, 2020

Study Completion

September 5, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

KR(1)