LAMS: Efficacy and Safety of Lumen Apposing Metal Stents

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Recruiting

CT.gov ID

NCT03903523

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

250

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Obstruction	Device: Lumen apposing metal stent (LAMS)

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy and Safety of Lumen Apposing Metal Stents: a Retrospective Multicentre Study

Actual Study Start Date :

Apr 30, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano	Italy	20089
2	Humanitas Research Hospital	Milano		Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator: Andrea Anderloni, MD, Humanitas Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT03903523

Other Study ID Numbers:

First Posted:

Apr 4, 2019

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 17, 2020