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OpenTrials
Completed

NCT Number: NCT04024930

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

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.

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Key information

Conditions

EUS Guided Biliary Drainage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital University, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. technical success rate

    Time frame: 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 outcomes

  1. Clinical success

    Time frame: Day 28

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

  2. Periprocedural adverse events: adverse events that occur during the procedure

    Time frame: 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.

  3. short-term adverse events

    Time frame: 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.

  4. Long-term biliary adverse events: biliary adverse events that occur after discharge from hospital.

    Time frame: 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.

  5. Six month stent patency rate

    Time frame: Month 6

    rate of permeability of the stent 6 months after the procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.