Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02937246
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Malignant Tumor Device: SEMS(self-expandable metallic stent) Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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 Name: Obstructive jaundice decompression with endoscopic metal stenting

Active Comparator: the control group
Uncovered double bare metal stent
Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)



Primary Outcome Measures :
  1. Mean duration of stent patency [ Time Frame: 6 months after stenting ]
    Check the duration until the date of obstruction of inserted stent within 6 months after stenting


Secondary Outcome Measures :
  1. Patency rate of stent [ Time Frame: 6 months after stenting ]
  2. Overall survival [ Time Frame: 6 months after stenting ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937246


Contacts
Layout table for location contacts
Contact: Seung Min Bang, MD 82-2-2228-5190 bang7028@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seungmin Bang, MD    02-2228-5190    Bang7028@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02937246     History of Changes
Other Study ID Numbers: 4-2015-1147
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms