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OpenTrials
Completed

NCT Number: NCT05761496

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

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

Completed

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Key information

Conditions

Biliary Stricture Stent Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biliary stents insertion

Device

Endoscopic placement of plastic and metal biliary stents

Primary outcomes

  1. Evaluation of the potency of biliary stents (plastic and metal)

    Time frame: through study completion, an average of 1 year

    Time to occurrence of jaundice/cholangitis

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PROTESIED

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2023
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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