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

Malignant Tumor Clinical Trial

Official title:

Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction: A Multicenter Prospective Randomized Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02937246
• Other study ID #: 4-2015-1147
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Device:
• SEMS(self-expandable metallic stent)
Find the obstruction site by ERCP(endoscopic retrograde cholangiopancreatography) and insertion the SEMS(self-expandable metallic stent) through duodenal endoscopy. Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.
• Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean duration of stent patency	Check the duration until the date of obstruction of inserted stent within 6 months after stenting	6 months after stenting
Secondary	Patency rate of stent		6 months after stenting
Secondary	Overall survival		6 months after stenting