Evaluation of the Performances of a Single-Use Duodenoscope: A Prospective Multicentre French Study (The Exaltes Study)

Aims A single-use duodenoscope (SUD) has been recently developed to overcome issues with ERCP-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study.

Methods We conducted a prospective, multi-centre single-arm study enrolling all consecutive patients undergoing ERCP in six French centres. All ERCP were performed with the SUD and, in case of failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety, and operators’ satisfaction (VAS scale 0-10 and 22 qualitative items). The study protocol was approved by the French authority and registered (ID-RCB: 2020-A00346-33). An external company anonymously collected the database and performed the statistical analysis.

Results Sixty patients (34 females, median age 65.5-year-old) were enrolled. Main indications were CBD stones (41.7 %), malignant biliary obstruction (26.7 %) and chronic pancreatitis (20.0 %). Most ERCP were considered ASGE grade 2 (56.7 %) or 3 (35.0 %). Fifty-seven (95.0 %) procedures have been successfully completed using the SUD. Failures were unrelated to SUD use (1 duodenal stricture, 1 ampullary infiltration, and 1 complete biliary stricture); reusable duodenoscopes did not allow to accomplish the procedures. These patients were treated with surgery, EUS-guided drainage, and intervention radiology, respectively. Median operators’ satisfaction was 9 [7-9]. Qualitative assessments were considered clinically satisfactory in a median of 100 % of items and comparable to a reusable duodenoscope in 97.9 % of items. No SUD-related adverse event (AE) was observed. Three patients (5 %) reported an AE (pain after biliary stenting, mild pancreatitis, and pancreatic carcinoma disease progression to death).

Conclusions The use of a SUD allows accomplishing ERCP with an optimal successful rate and safety. Our data show that SUD could be used for several ERCP indications and complexity. The clinical applications and systematic use of SUD should be assessed by dedicated trials.

Citation: Napoleon B, Gonzalez JM, Grandval P et al. OP31 EVALUATION OF THE PERFORMANCES OF A SINGLE-USE DUODENOSCOPE: A PROSPECTIVE MULTICENTRE FRENCH STUDY (THE EXALTES STUDY). Endoscopy 2021; 53: S16.

Publication History

Article published online:
19 March 2021