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

Completed

• Conditions: EUS Guided Biliary Drainage

• Registration Number: NCT04024930
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-10-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
technical success rate	Day 1	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

Secondary Outcome Measures

Name	Time	Method
Clinical success	Day 28	Number of participants with a decrease in the bilirubin level ≥ 50% at day 7, or normalization at day 28
Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.	Year 1	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.
Periprocedural adverse events: adverse events that occur during the procedure	Day 1	Number of participants with an adverse event occuring during the procedure of EUS-CDS. ASGE lexicon will be used to grade these adverse events.
short-term adverse events	Day 7	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.
Six month stent patency rate	Month 6	rate of permeability of the stent 6 months after the procedure

Trial Locations

Locations (7)

Hospital University; 🇫🇷 Brest, France

University Hospital; 🇫🇷 Montpellier, France

APHP Hospital Saint-Antoine; 🇫🇷 Paris, France

Hospital Private Jean MERMOZ; 🇫🇷 Lyon, France

APHM Hospital La Timone; 🇫🇷 Marseille, France

Hospital Cournouaille; 🇫🇷 Quimper, France

Hospital Jacques Lacarin; 🇫🇷 Vichy, France