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

EUS Guided Biliary Drainage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024930
• Other study ID #: 87RI18_0034
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• EUS Guided Biliary Drainage

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical success	Number of participants with a decrease in the bilirubin level = 50% at day 7, or normalization at day 28	Day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	Six month stent patency rate	rate of permeability of the stent 6 months after the procedure	Month 6