Biliary ObstructionLAMSNCT03903523
Efficacy and Safety of Lumen Apposing Metal Stents
An observational study of Biliary Obstruction, run by Istituto Clinico Humanitas at 2 sites in Italy.
Trial summary
Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role. The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction
- What is being tested?
- Lumen apposing metal stent (LAMS)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Apr 2019to 31 Dec 2023
- 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: Retrospective analysis of a prospectively maintained database of all consecutive patients with distal malignat biliary obstruction, high surgical risk acute cholecystitis, or symptomatic pancreatic fluid collection that underwent EUS drainage from January 2016 to December 2022. All EUS drainage were performed by experienced operators.
Who may be able to join
- Age ≥18 years
- Patients with distal malignant common bile duct obstruction with failed ERCP
- Patients with symptomatic peripancreatic fluid collections
- Patients with acute cholecystitis who are unfit for surgery
- Agree to receive follow up phone calls
- Able to provide written informed consent
Who cannot join
- Coagulation and/or platelets hereditary disorders.
- Pregnant women
- Inability to sign the informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Not yet recruiting
Humanitas Research Hospital
Milan, 20089
Andrea Anderloni, MD
- Recruiting
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Repici, MD, +39282247493, alessandro.repici@humanitas.it
Alessandro Repici, MD
About this study
Official title: Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study
Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role.
The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication.
Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.
- Conditions
- Biliary Obstruction
- Being tested
- Lumen apposing metal stent (LAMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen apposing metal stent (LAMS)Device
Stent positioning
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the rate of technical and clinical success of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of lumen apposing metal stents
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start30 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Anderloni, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903523
- Sponsor's protocol ID
- 970
- Acronym
- LAMS
- Status last verified
- Sep 2022
- First submitted
- 2 Apr 2019
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, Di Mitri R, Cugia L, Pollino V, Macchiarelli R, Mangiavillano B, Forti E, Brancaccio ML, Badas R, Maida M, Sinagra E, Repici A, Fabbri C, Tarantino I. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointest Endosc. 2023 Nov;98(5):765-773. doi: 10.1016/j.gie.2023.06.054. Epub 2023 Jun 29.
PubMed 37392954Fugazza A, Fabbri C, Di Mitri R, Petrone MC, Colombo M, Cugia L, Amato A, Forti E, Binda C, Maida M, Sinagra E, Repici A, Tarantino I, Anderloni A; i-EUS Group. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis. Gastrointest Endosc. 2022 May;95(5):896-904.e1. doi: 10.1016/j.gie.2021.12.032. Epub 2022 Jan 4.
PubMed 34995640Facciorusso A, Amato A, Crino SF, Sinagra E, Maida M, Fugazza A, Binda C, Coluccio C, Repici A, Anderloni A, Tarantino I, Fabbri C; i-EUS Group. Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study. Gastrointest Endosc. 2022 Jun;95(6):1158-1172. doi: 10.1016/j.gie.2021.12.006. Epub 2021 Dec 18.
PubMed 34932991
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study
- ClinicalTrials.gov ID
- NCT03903523
- Acronym / sponsor ID
- LAMS / 970
- Conditions
- Biliary Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Apr 2019 (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.
Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role.
The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication.
Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.
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
- Retrospective analysis of a prospectively maintained database of all consecutive patients with distal malignat biliary obstruction, high surgical risk acute cholecystitis, or symptomatic pancreatic fluid collection that underwent EUS drainage from January 2016 to December 2022. All EUS drainage were performed by experienced operators.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Patients with distal malignant common bile duct obstruction with failed ERCP
- Patients with symptomatic peripancreatic fluid collections
- Patients with acute cholecystitis who are unfit for surgery
- Agree to receive follow up phone calls
Key exclusion criteria (3 listed)
- Coagulation and/or platelets hereditary disorders.
- Pregnant women
- Inability to sign the informed consent
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 |
|---|---|---|
| Lumen apposing metal stent (LAMS)Stent positioning | Device | – |
Primary outcome
Evaluate the rate of technical and clinical success of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of lumen apposing metal stents
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Derived from this study: PubMed 37392954Binda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, Di Mitri R, Cugia L, Pollino V, Macchiarelli R, Mangiavillano B, Forti E, Brancaccio ML, Badas R, Maida M, Sinagra E, Repici A, Fabbri C, Tarantino I. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointest Endosc. 2023 Nov;98(5):765-773. doi: 10.1016/j.gie.2023.06.054. Epub 2023 Jun 29.
- Derived from this study: PubMed 34995640Fugazza A, Fabbri C, Di Mitri R, Petrone MC, Colombo M, Cugia L, Amato A, Forti E, Binda C, Maida M, Sinagra E, Repici A, Tarantino I, Anderloni A; i-EUS Group. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis. Gastrointest Endosc. 2022 May;95(5):896-904.e1. doi: 10.1016/j.gie.2021.12.032. Epub 2022 Jan 4.
- Derived from this study: PubMed 34932991Facciorusso A, Amato A, Crino SF, Sinagra E, Maida M, Fugazza A, Binda C, Coluccio C, Repici A, Anderloni A, Tarantino I, Fabbri C; i-EUS Group. Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study. Gastrointest Endosc. 2022 Jun;95(6):1158-1172. doi: 10.1016/j.gie.2021.12.006. Epub 2021 Dec 18.
- Individual participant dataSharing planned: No
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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 Anderloni, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Obstruction, run by Istituto Clinico Humanitas at 2 sites 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Anderloni, MD (0039-02-82247308, andrea.anderloni@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rate of technical and clinical success of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of lumen apposing metal stents (time frame: 6 years). 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 NCT03903523, which also lists 3 linked publications.
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 14 Sep 2022.