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

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.

Study Overview

• Status: Completed
• Conditions: EUS Guided Biliary Drainage

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Brest, France, 29600
    • Hospital University
  • Limoges, France, 87042
    • University Hospital
  • Lyon, France, 69008
    • Hospital Private Jean MERMOZ
  • Marseille, France, 29600
    • APHM Hospital La Timone
  • Montpellier, France, 34295
    • University Hospital
  • Paris, France, 75012
    • APHP Hospital Saint-Antoine
  • Quimper, France, 29000
    • Hospital Cournouaille
  • Vichy, France, 03200
    • Hospital Jacques Lacarin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success rate	Technical success was defined as the ability to correctly deploy the Hot AXIOS stent between the common bile duct and the duodenal bulb with visualization of bile flow	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Number of participants with a decrease in the bilirubin level ≥ 50% at day 7, or normalization at day 28	Day 28
Periprocedural adverse events: adverse events that occur during the procedure	Number of participants with an adverse event occuring during the procedure of EUS-CDS. ASGE lexicon will be used to grade these adverse events.	Day 1
short-term adverse events	Number of participants with an adverse event occuring between the procedure and discharge from hospital. Adverse events were rated according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon will be used to grade these adverse events.	Day 7
Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.	Number of participants with a biliary adverse event occuring after discharge from hospital. Adverse events were rated according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon will be used to grade these adverse events.	Year 1
Six month stent patency rate	rate of permeability of the stent 6 months after the procedure	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: EUS guided biliairy drainage; EUS Choledoco-duodenostomy; Axios stent; Lumen Apposing Metal Stent
• Other Study ID Numbers: 87RI18_0034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No