EUS GUIDED CHOLEDOCODUODENOSTOMY WITH HOT AXIOS: FRENCH MULTICENTRIC STUDY AFTER LEARNING CURVE

Aims:

Eus guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by ERCP. Recently we reported a good efficiency of EUS guided choledocoduodenostomy using the HOT AXIOS in a retrospective multicentric study. However in this study, technical success was 88.5%. Utilization of the recommended technique (direct ponction of the common bile duct with the HOT AXIOS + using a 6 mm Stent + fistulotomy with a pure section current) was the only predciting factor of clinical success.

We decide to reevaluate this procedure one year after in the same centers.

Methods:

French retrospective multicentric study including all cases of EUS guided CDS with HOT AXIOS device in the 7 centers that participate to the first study.

Primary ENDPOINT: technical success rate 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 endpoints: decrease in bilirubin of at least 50% at day 7 or normalization at day 30.

and clinical success rate, per procedural complication rate, short-term complications (all complications occurring between the procedure and discharge from the hospital).

Results:

61 consecutive patients were included in this study between 01/09/2017 and 22/09/2018 by 11 operators in 9 centers.

Primary Endpoint: Technical success rate was 98.5% with only one failure.

Secondary Endpoints:

Clinical success rate: 98.4%.

Per procedural complication: 1.6%: one bleeding during the fistulotomy stopped by the stent itself.

Short term complications: 0%.

Recurrence of biliary obstruction: 7 cases (11.5%) (median follow up: 151 days).

Conclusions:

EUS-CDS with the HOT AXIOS is efficacious and safe in distal malignant obstruction of the common bile duct in cases of ERCP failure with impressive results once the expertise is acquired and the recommended technic is followed.