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Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]

NCT ID: NCT04024930

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-10-30

Brief Summary

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Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.

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Detailed Description

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Conditions

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EUS Guided Biliary Drainage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS

Exclusion Criteria

* \< 18 years old
* refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital University

Brest, , France

Site Status

University Hospital

Limoges, , France

Site Status

Hospital Private Jean MERMOZ

Lyon, , France

Site Status

APHM Hospital La Timone

Marseille, , France

Site Status

University Hospital

Montpellier, , France

Site Status

APHP Hospital Saint-Antoine

Paris, , France

Site Status

Hospital Cournouaille

Quimper, , France

Site Status

Hospital Jacques Lacarin

Vichy, , France

Site Status

Countries

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France

Other Identifiers

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87RI18_0034

Identifier Type: -

Identifier Source: org_study_id

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