EUS Guided Biliary Drainage
Conditions
Keywords
EUS guided biliairy drainage, EUS Choledoco-duodenostomy, Axios stent, Lumen Apposing Metal Stent
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.
Interventions
None listed
Sponsors
University Hospital, Limoges
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | Day 28 | Number of participants with a decrease in the bilirubin level ≥ 50% at day 7, or normalization at day 28 |
| 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. |
| 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. |
| Six month stent patency rate | Month 6 | rate of permeability of the stent 6 months after the procedure |
Countries
France
Outcome results
None listed