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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Tumor
• Intervention / Treatment: Device: SEMS(self-expandable metallic stent); Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; Partial covered double bare metal stent	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.; Other Names: Obstructive jaundice decompression with endoscopic metal stenting
Active Comparator: the control group; Uncovered double bare metal stent	Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Patency rate of stent	6 months after stenting
Overall survival	6 months after stenting

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 4-2015-1147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No