Clinical trial NCT03849859: 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
Overall status: TERMINATED
Phase: NA
Conditions: Plastic Stent Occlusion
Keywords: Plastic stent
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative stent patency
timeFrame: From the date of randomization though the study completion, assessed up to 1 year.
measure: Clinical success rate
timeFrame: Four weeks after randomization
Secondary outcomes:
measure: Overall adverse events
timeFrame: From the date of randomization until the date of documented adverse events, assessed up to 1 month.
measure: Overall patient survival
timeFrame: From the date of randomization until the date of death from any cause, assessed up to 12 months.
measure: Procedure relate death
timeFrame: From the date of randomization until the date of death from procedure within 7 days
measure: Technical success rate
timeFrame: From the date of randomization until the last stent deploy, assessed up to 1 day.
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkhla
city: Hat Yai
country: Thailand
facility: NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology.
name: Ni Netinatsunton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: