Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.

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.

Study Overview

• Status: Terminated
• Conditions: Plastic Stent Occlusion
• Intervention / Treatment: Device: Single plastic stent; Device: Multiple plastic stents

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

In-operable distal malignant bile duct obstruction Age>18

Exclusion Criteria:

Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single plastic stent; Deployment of single plastic stent	Device: Single plastic stent; Deployment of single plastic stent
Active Comparator: Multiple plastic stents; Deployment of multiple plastic stent	Device: Multiple plastic stents; Deployment of multiple plastic stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative stent patency	Proportion of patients with documented stent dysfunction	From the date of randomization though the study completion, assessed up to 1 year.
Clinical success rate	Proportion of patients with total bilirubin level declining > 50 % of the initial value	Four weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall adverse events	Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.	From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Overall patient survival	Proportion of patients who die from any causes.	From the date of randomization until the date of death from any cause, assessed up to 12 months.
Procedure relate death	Proportion of patients who die from complications related procedure.	From the date of randomization until the date of death from procedure within 7 days
Technical success rate	Proportion of patient who successful underwent stent placement.	From the date of randomization until the last stent deploy, assessed up to 1 day.

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Ni Netinatsunton, M.D., NKC Institute of Gastroenterology and Hepatology.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopic Retrograde Cholangiopancreatography; Plastic stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis
• Other Study ID Numbers: REC.61-096-21-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No