Efficacy and Safety of Lumen Apposing Metal Stents

NCT03903523 | Unknown

• 1 other identifier: 970
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 years

Interventions

Lumen apposing metal stent (LAMS) DEVICE

Stent positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Coagulation and/or platelets hereditary disorders.
• Pregnant women
• Inability to sign the informed consent

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (2)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Humanitas Research Hospital

Milan, 20089, Italy

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 37392954 DERIVED

• Fugazza 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.

  PMID: 34995640 DERIVED

• Facciorusso 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.

  PMID: 34932991 DERIVED

Study Officials

• Andrea Anderloni, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Anderloni, MD

CONTACT

0039-02-82247308; andrea.anderloni@humanitas.it

Alessandro Fugazza, MD

CONTACT

0039-02-82247021; alessandro.fugazza@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: April 30, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)