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

Study Overview
=================
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.

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

Conditions
-----------------
EUS Guided Biliary Drainage

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EUS guided biliairy drainage, EUS Choledoco-duodenostomy, Axios stent, Lumen Apposing Metal Stent