Back to resultsSingle Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction
Primary Purpose
Plastic Stent Occlusion
Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Single plastic stent
Multiple plastic stents
Sponsored by
About this trial
This is an interventional treatment trial for Plastic Stent Occlusion focused on measuring Plastic stent, Endoscopic Retrograde Cholangiopancreatography
Eligibility Criteria
Inclusion Criteria:
In-operable distal malignant bile duct obstruction Age>18
Exclusion Criteria:
Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Sites / Locations
- NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
- NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single plastic stent
Multiple plastic stents
Arm Description
Deployment of single plastic stent
Deployment of multiple plastic stent
Outcomes
Primary Outcome Measures
Cumulative stent patency
Proportion of patients with documented stent dysfunction
Clinical success rate
Proportion of patients with total bilirubin level declining > 50 % of the initial value
Secondary Outcome Measures
Overall adverse events
Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.
Overall patient survival
Proportion of patients who die from any causes.
Procedure relate death
Proportion of patients who die from complications related procedure.
Technical success rate
Proportion of patient who successful underwent stent placement.
Full Information
NCT ID
NCT03849859
First Posted
February 13, 2019
Last Updated
March 26, 2021
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT03849859
Brief Title
Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction
Official Title
A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of difficulty in completing the study as originally planned and loss of extra-funding.
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plastic Stent Occlusion
Keywords
Plastic stent, Endoscopic Retrograde Cholangiopancreatography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single plastic stent
Arm Type
Active Comparator
Arm Description
Deployment of single plastic stent
Arm Title
Multiple plastic stents
Arm Type
Active Comparator
Arm Description
Deployment of multiple plastic stent
Intervention Type
Device
Intervention Name(s)
Single plastic stent
Intervention Description
Deployment of single plastic stent
Intervention Type
Device
Intervention Name(s)
Multiple plastic stents
Intervention Description
Deployment of multiple plastic stents
Primary Outcome Measure Information:
Title
Cumulative stent patency
Description
Proportion of patients with documented stent dysfunction
Time Frame
From the date of randomization though the study completion, assessed up to 1 year.
Title
Clinical success rate
Description
Proportion of patients with total bilirubin level declining > 50 % of the initial value
Time Frame
Four weeks after randomization
Secondary Outcome Measure Information:
Title
Overall adverse events
Description
Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.
Time Frame
From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Title
Overall patient survival
Description
Proportion of patients who die from any causes.
Time Frame
From the date of randomization until the date of death from any cause, assessed up to 12 months.
Title
Procedure relate death
Description
Proportion of patients who die from complications related procedure.
Time Frame
From the date of randomization until the date of death from procedure within 7 days
Title
Technical success rate
Description
Proportion of patient who successful underwent stent placement.
Time Frame
From the date of randomization until the last stent deploy, assessed up to 1 day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In-operable distal malignant bile duct obstruction Age>18
Exclusion Criteria:
Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ni Netinatsunton, M.D.
Organizational Affiliation
NKC Institute of Gastroenterology and Hepatology.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction
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