Who is sponsoring NCT04805450?

NCT04805450 is sponsored by Istituto Clinico Humanitas.

What drugs are being tested in NCT04805450?

Interventions in NCT04805450: ES before fully covered SEMS placement, no ES before fully covered SEMS placement.

What condition does NCT04805450 study?

NCT04805450 studies Malignant Bile Duct Obstruction.

Is NCT04805450 still recruiting?

NCT04805450 is currently status unknown. Last updated 21 March 2023.

Last reviewed 2023-03-21 · How we verify

NCT04805450: SEMS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Status unknown NA Last updated 21 March 2023

What this trial tests

NA trial testing ES before fully covered SEMS placement in Malignant Bile Duct Obstruction in 1,075 participants. Status unknown.

Timeline

1 October 2015

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,075
Start date	1 October 2015
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Italy

Drugs / interventions tested

ES before fully covered SEMS placement
no ES before fully covered SEMS placement

Conditions studied

Malignant Bile Duct Obstruction — all drugs for Malignant Bile Duct Obstruction →

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Malignant Bile Duct Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\]. The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04805450 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
Last refreshed: 21 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04805450.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing