Global prospective case series of ERCPs using a single-use duodenoscope.
Endoscopy
; 55(12): 1103-1114, 2023 Dec.
Article
em En
| MEDLINE
| ID: mdl-37463599
ABSTRACT
BACKGROUND:
The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas.METHODS:
61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥â18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).RESULTS:
Among 551 patients, 236 (42.8â%) were aged >â65, 281 (51.0â%) were men, and 256 (46.5â%) had their procedure as an inpatient. ERCPs included 196 (35.6â%) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0â%) were completed 503 (91.3â%) using only the single-use duodenoscope, and 26 (4.7â%) with crossover to a reusable endoscope. There were 22 ERCPs (4.0â%) that were not completed, of which 11 (2.0â%) included a crossover and 11 (2.0â%) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8â%), including 17 (3.1â%) who developed post-ERCP pancreatitis.CONCLUSIONS:
In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pancreatite
/
Colangiopancreatografia Retrógrada Endoscópica
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article