NCT01141088

Two Bilateral Metal Stenting in Hilar Malignancy

Status unknown NA Last updated 19 December 2017

What this trial tests

NA trial testing Bilateral stent-in-stent insertion in Malignant Hilar Stricture in 80 participants. Status unknown.

Timeline

1 April 2016

Primary endpoint
30 March 2018

30 September 2018

Quick facts

Lead sponsor	Soon Chun Hyang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 April 2016
Primary completion	30 March 2018
Estimated completion	30 September 2018
Sites	2 locations across South Korea

Drugs / interventions tested

• Bilateral stent-in-stent insertion
• Bilateral side-by-side insertion

Conditions studied

• Malignant Hilar Stricture — all drugs for Malignant Hilar Stricture →
• Bilateral Stent Insertion — all drugs for Bilateral Stent Insertion →

Sponsor

Soon Chun Hyang University

Who can join

18 and older, any sex, with Malignant Hilar Stricture or Bilateral Stent Insertion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making allative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. In malignant hilar obstruction, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex, and it may require multiple procedures, with an increased risk of complications and mortality. To overcome this difficulty and strategize plan of management, the investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of stent-in-stent method for the management of malignant hilar obstruction.

Publications & conference data

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

1. Prospective comparison of endoscopic bilateral stent-in-stent versus stent-by-stent deployment for inoperable advanced malignant hilar biliary stricture.
   Lee TH, Moon JH, Choi JH, Lee SH, et al · · 2019 · cited 69× · PMID 30905729 · DOI 10.1016/j.gie.2019.03.011