Biliary StricturePROTESIEDNCT05761496
Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.
An observational study of Biliary Stricture and Stent Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture, Stent Stenosis
- What is being tested?
- Biliary stents insertion
- Type of treatment
- Medical device
- How many people
- 871 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2020to 31 Dec 2022
- How long will I take part?
- 12 Months
- 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
- Adult, Older adult
Study population: Patients requiring for the first time drainage of malignant distal biliary stricture
Who may be able to join
- Malignant distal biliary stricture
- Need for Palliative and pre-operative biliary drainage
- Age > 18
- Signature of the informed consent
Who cannot join
- Previous endoscopic/radiological biliary drainage
- Stricture close to the main hepatic confluence(< 2 cm)
- Duodenal stenosis
- Post- surgical altered anatomy
- Benign disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.
Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures
- Conditions
- Biliary Stricture, Stent Stenosis
- Being tested
- Biliary stents insertion
- Keywords
- Biliary stricture, Plastic stent, Self Expandable Metal stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary stents insertionDevice
Endoscopic placement of plastic and metal biliary stents
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the potency of biliary stents (plastic and metal)
Time to occurrence of jaundice/cholangitis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start7 Jan 2020
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 871 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tringali Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Tringali, MD, PhD, Principal investigator, Fondazione Policlinico Gemelli IRCCS, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761496
- Sponsor's protocol ID
- 2767
- Acronym
- PROTESIED
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schepis T, Zagari RM, Crino SF, Sacco M, Palmeri E, Grassia R, Santagati A, Venezia G, Olivari N, Panarese A, Mutignani M, Biviano I, Bertani H, Devani M, de Minicis S, de Roberto G, Aucello A, Pallio S, Gabbrielli A, Milluzzo SM, Parodi MC, Pasquale L, Costamagna G, Dajti E, Tringali A; and the PROTESIED Study Group. Adherence to ESGE guidelines on biliary stenting in malignant distal strictures: Results from a prospective Italian registry. Endosc Int Open. 2026 Jan 26;14:a27779199. doi: 10.1055/a-2777-9199. eCollection 2026.
PubMed 41704862
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.
- ClinicalTrials.gov ID
- NCT05761496
- Acronym / sponsor ID
- PROTESIED / 2767
- Conditions
- Biliary Stricture, Stent Stenosis
- Keywords
- Biliary stricture, Plastic stent, Self Expandable Metal stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Mar 2023 (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.
Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients requiring for the first time drainage of malignant distal biliary stricture
Key inclusion criteria (4 listed)
- Malignant distal biliary stricture
- Need for Palliative and pre-operative biliary drainage
- Age > 18
- Signature of the informed consent
Key exclusion criteria (5 listed)
- Previous endoscopic/radiological biliary drainage
- Stricture close to the main hepatic confluence(< 2 cm)
- Duodenal stenosis
- Post- surgical altered anatomy
- Benign disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biliary stents insertionEndoscopic placement of plastic and metal biliary stents | Device | – |
Primary outcome
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
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 13 Nov 2024.
- Derived from this study: PubMed 41704862Schepis T, Zagari RM, Crino SF, Sacco M, Palmeri E, Grassia R, Santagati A, Venezia G, Olivari N, Panarese A, Mutignani M, Biviano I, Bertani H, Devani M, de Minicis S, de Roberto G, Aucello A, Pallio S, Gabbrielli A, Milluzzo SM, Parodi MC, Pasquale L, Costamagna G, Dajti E, Tringali A; and the PROTESIED Study Group. Adherence to ESGE guidelines on biliary stenting in malignant distal strictures: Results from a prospective Italian registry. Endosc Int Open. 2026 Jan 26;14:a27779199. doi: 10.1055/a-2777-9199. eCollection 2026.
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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.
Andrea Tringali, MD, PhD principal investigator
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
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 Biliary Stricture and Stent Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 5 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 13 Nov 2024. 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?
Evaluation of the potency of biliary stents (plastic and metal) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761496, which also lists 1 linked publication.
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 13 Nov 2024.