NCT02937246

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

3.5 years

First QC Date

October 13, 2016

Last Update Submit

June 21, 2019

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patency rate of stent

    6 months after stenting

  • Overall survival

    6 months after stenting

Study Arms (2)

the intervention group

EXPERIMENTAL

Partial covered double bare metal stent

Device: SEMS(self-expandable metallic stent)

the control group

ACTIVE COMPARATOR

Uncovered double bare metal stent

Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)

Interventions

SEMS(self-expandable metallic stent)DEVICE

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.

Also known as: Obstructive jaundice decompression with endoscopic metal stenting
the intervention group
Stenting by ERCP (endoscopic retrograde cholangiopancreatography)DEVICE
the control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 36084714DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 18, 2016

Study Start

May 31, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 24, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)