NCT03439020

The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent

Completed NA Last updated 21 November 2019

What this trial tests

NA trial testing Plastic stent anchoring in Malignant Biliary Stricture in 70 participants. Completed in 31 October 2019.

Timeline

26 February 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	26 February 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Plastic stent anchoring
• FCSEMS

Conditions studied

• Malignant Biliary Stricture — all drugs for Malignant Biliary Stricture →

Sponsor

Seoul National University Hospital

Who can join

20 and older, any sex, with Malignant Biliary Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to demonstrate that the group with an additional plastic stent to anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant biliary stricture has less stent migration than the group with FCSEMS only. The primary outcome is stent migration for 6 months. The secondary outcomes are stent related adverse events, stent patency, and overall survival.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in Endoscopic Management of Distal Biliary Stricture: Integrating Clinical Evidence into Patient-Specific Decision-Making.
   Yamada R, Miwata T, Nakamura Y, Nose K, et al · · 2025 · cited 1× · PMID 40867273 · DOI 10.3390/cancers17162644