Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction

Yonsei University

Status: Unknown

Conditions: Malignant Tumor

Treatments: Device: SEMS(self-expandable metallic stent); Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

Study type: Interventional

Funder types: Other

Identifiers

NCT02937246

4-2015-1147

Details and patient eligibility

About

Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.

Full description

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months. In order to minimize the occurrence of this issue, covered stents were developed. Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.

Enrollment: 260 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
• malignant biliary obstruction was located more than 1cm from the hilum
• older than 20 years old
• Life expectancy > 6 months
• Inoperable case due to advanced stage or comorbidity
• Informed consent obtained

Exclusion criteria

• Inadequate case for ERCP
• Failed endoscopic approach to duodenum or biliary tract
• biliary obstruction was located at hilum or IHD
• patients with uncontrolled infection
• Pregnancy
• No signed informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

the intervention group

Experimental group

Description:

Partial covered double bare metal stent

Treatment:

Device: SEMS(self-expandable metallic stent)

the control group

Active Comparator group

Description:

Uncovered double bare metal stent

Treatment:

Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)