Common Bile Duct StrictureNEOSTENTNCT05395013
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
An observational study of Common Bile Duct Stricture and Jaundice; Malignant, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Stricture, Jaundice; Malignant
- How many people
- 3,149 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin who underwent endoscopic drainage
Who may be able to join
- Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin
- Patients > 18 years old
- Obtaining informed consent
Who cannot join
- Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available <1 month
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice.
The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.
The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.
However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.
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.
- Conditions
- Common Bile Duct Stricture, Jaundice; Malignant
- Keywords
- Biliary Stent, Jaundice, Pancreatic cancer, Common bile duct cancer
- Medical subject headings
- Jaundice, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 2017 to 2021
Secondary outcomes (3)
Rate of adverse events
Rate of periprocedural complications (i.e. bleeding, pancreatitis, cholecystitis) after biliary stent placement
Measured: From 2017 to 2021
Rate of endoscopic reintervention
Rate of stent disfunction requiring an additional endoscopic procedure
Measured: From 2017 to 2021
Rate of biliary cannulation and successful stent placement
Rate of biliary cannulation and successful stent placement
Measured: From 2017 to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Nov 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unità Sanitaria Locale della Romagna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Fabbri, Azienda Unità Sanitaria Locale della Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395013
- Sponsor's protocol ID
- 3196
- Acronym
- NEOSTENT
- Status last verified
- Jun 2022
- First submitted
- 13 Nov 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
- ClinicalTrials.gov ID
- NCT05395013
- Acronym / sponsor ID
- NEOSTENT / 3196
- Conditions
- Common Bile Duct Stricture, Jaundice; Malignant
- Keywords
- Biliary Stent, Jaundice, Pancreatic cancer, Common bile duct cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,149 participants (actual)
- Lead sponsor
- Azienda Unità Sanitaria Locale della RomagnaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice.
The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.
The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.
However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin who underwent endoscopic drainage
Key inclusion criteria (3 listed)
- Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin
- Patients > 18 years old
- Obtaining informed consent
Key exclusion criteria (1 listed)
- Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available <1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bilirubin decrease
Time frame: From 2017 to 2021
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
3 secondary outcomes
Rate of adverse events
Time frame: From 2017 to 2021
Rate of endoscopic reintervention
Time frame: From 2017 to 2021
Rate of biliary cannulation and successful stent placement
Time frame: From 2017 to 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Stricture and Jaundice; Malignant, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilirubin decrease (time frame: From 2017 to 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.