Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05761496

Acronym

PROTESIED

Enrollment

871

Registered

2023-03-09

Start date

2020-01-07

Completion date

2022-12-31

Last updated

2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Stricture, Stent Stenosis

Keywords

Biliary stricture, Plastic stent, Self Expandable Metal stent

Brief summary

Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures

Interventions

DEVICEBiliary stents insertion

Endoscopic placement of plastic and metal biliary stents

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Malignant distal biliary stricture * Need for Palliative and pre-operative biliary drainage * Age \> 18 * Signature of the informed consent

Exclusion criteria

* Previous endoscopic/radiological biliary drainage * Stricture close to the main hepatic confluence(\< 2 cm) * Duodenal stenosis * Post- surgical altered anatomy * Benign disease

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the potency of biliary stents (plastic and metal)	through study completion, an average of 1 year	Time to occurrence of jaundice/cholangitis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026