Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

NCT03849859 | Terminated DMC

• 1 other identifier: REC.61-096-21-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Plastic Stent Occlusion

Keywords

Plastic stent; Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall adverse events

  From the date of randomization until the date of documented adverse events, assessed up to 1 month.

• Overall patient survival

  From the date of randomization until the date of death from any cause, assessed up to 12 months.

• Procedure relate death

  From the date of randomization until the date of death from procedure within 7 days

• Technical success rate

  From the date of randomization until the last stent deploy, assessed up to 1 day.

Study Arms (2)

Single plastic stent

ACTIVE COMPARATOR

Deployment of single plastic stent

Device: Single plastic stent

Multiple plastic stents

ACTIVE COMPARATOR

Deployment of multiple plastic stent

Device: Multiple plastic stents

Interventions

Single plastic stent DEVICE

Deployment of single plastic stent

Single plastic stent

Multiple plastic stents DEVICE

Deployment of multiple plastic stents

Multiple plastic stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In-operable distal malignant bile duct obstruction Age\>18

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (2)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Study Officials

• Ni Netinatsunton, M.D.

  NKC Institute of Gastroenterology and Hepatology.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 21, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: November 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)