Clinical trial NCT02937246: Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 260
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean duration of stent patency
timeFrame: 6 months after stenting
Secondary outcomes:
measure: Patency rate of stent
timeFrame: 6 months after stenting
measure: Overall survival
timeFrame: 6 months after stenting
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
References:
citation: Park SW, Lee KJ, Chung MJ, Jo JH, Lee HS, Park JY, Park SW, Song SY, Kang H, Kim EJ, Kim YS, Cho JH, Bang S. Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial. Gastrointest Endosc. 2023 Jan;97(1):132-142.e2. doi: 10.1016/j.gie.2022.08.041. Epub 2022 Sep 7.