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

University Hospital, Limoges70 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

EUS Guided Biliary Drainage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Hospital University

Brest, France

University Hospital

Limoges, France

Hospital Private Jean MERMOZ

Lyon, France

APHM Hospital La Timone

Marseille, France

University Hospital

Montpellier, France

APHP Hospital Saint-Antoine

Paris, France

Hospital Cournouaille

Quimper, France

Hospital Jacques Lacarin

Vichy, France

Outcomes

Primary Outcomes

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

Time frame: Day 1

Secondary Outcomes

Clinical success

Number of participants with a decrease in the bilirubin level ≥ 50% at day 7, or normalization at day 28

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Year 1

Six month stent patency rate

rate of permeability of the stent 6 months after the procedure

Time frame: Month 6