Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
NEOSTENT
1 other identifier
observational
3,149
1 country
1
Brief Summary
The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJune 7, 2022
June 1, 2022
7 months
November 13, 2021
June 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bilirubin decrease
Rate of resolution of obstructive jaundice in short and long term (i.e. maintenance of patency and/or the need for reintervention) of the different types of biliary stent placed in patients with neoplastic stenosis of the common bile duct
From 2017 to 2021
Secondary Outcomes (3)
Rate of adverse events
From 2017 to 2021
Rate of endoscopic reintervention
From 2017 to 2021
Rate of biliary cannulation and successful stent placement
From 2017 to 2021
Eligibility Criteria
Patients with common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin who underwent endoscopic drainage
You may qualify if:
- Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin
- Patients \> 18 years old
- Obtaining informed consent
You may not qualify if:
- \- Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available \<1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Morgagni-Pierantoni
Forlì, Forlì-Cesena, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals
Study Record Dates
First Submitted
November 13, 2021
First Posted
May 27, 2022
Study Start
November 1, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06