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The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction

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ClinicalTrials.gov Identifier: NCT03279809
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Woo Hyun Paik, Seoul National University Hospital

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. We prospectively conducted 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 metalic stent patency, incidence of further procedures, and adverse events related with aspirin.

Condition or disease Intervention/treatment Phase
Biliary Stasis, Extrahepatic Drug: Aspirin Drug: Placebo Not Applicable

Detailed Description:

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, we prospectively conducted randomized controlled study with aspirin treated patients who received metal stents in patients over 20 years who were confirmed malignant distal biliary obstruction. We compared the incidence of stent dysfunction in both groups for 6 months after the procedure. Stent dysfunction is defined as any case which further procedure is required due to jaundice or cholangitis after stent insertion.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : September 12, 2019
Estimated Study Completion Date : September 5, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Intervention
Intervention : aspirin medication Case with aspirin medication for 6 months after stenting
Drug: Aspirin
Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction
Other Name: Aspirin 100 mg

Placebo Comparator: Control
Control : placebo medication Case with placebo medication for 6 months after stenting
Drug: Placebo
Case with placebo medication for 6 months after stenting
Other Name: Placebo drug of aspirin




Primary Outcome Measures :
  1. Incidence of stent dysfunction [ Time Frame: 6 months after biliary metalic stent ]
    Dysfunction after 6 months from stenting


Secondary Outcome Measures :
  1. Duration of metalic stent patency [ Time Frame: 6 months after biliary metalic stent ]
    Duration from insertion time to metallic stent dysfunction time

  2. Incidence of further procedures [ Time Frame: 6 months after biliary metalic stent ]
    Incidence of further procedures needed for biliary drainage

  3. Adverse events related with aspirin [ Time Frame: 6 months after biliary metalic stent ]
    Adverse events which clearly related with aspirin admistration including bleeding event



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279809


Contacts
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Contact: Woo Hyun Paik, MD, PhD 82-2-2072-2228 iatrus@hanmail.net
Contact: Jin Ho Choi, MD 82-2-2072-2228 pseudo.jh@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 110-744
Contact: Woo Hyun Paik, MD, PhD    82-2-2072-2228    iatrus@hanmail.net   
Contact: Jin Ho Choi, MD    82-2-2072-2228    pseudo.jh@gmail.com   
Sponsors and Collaborators
Woo Hyun Paik
Investigators
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Study Chair: Woo Hyun Paik, MD, PhD Seoul National University Hospital

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Responsible Party: Woo Hyun Paik, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03279809     History of Changes
Other Study ID Numbers: H-1707-161-874
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aspirin
Cholestasis
Cholestasis, Extrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics