B0458 - Assessment of the Learning Curve for Single-Use Disposable Duodenoscope for a Single Operator

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Nasir Saleem, MD

Indiana University School of Medicine
Indianapolis, IN

Nasir Saleem, MD¹, Yan Tong, PhD², Stuart Sherman, MD¹, Mark A. Gromski, MD¹
¹Indiana University School of Medicine, Indianapolis, IN; ²Indiana University, Indianapolis, IN

Introduction: In response to reports of duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the FDA has recommended a transition to duodenoscopes with innovative designs that may include disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for disposable duodenoscopes, to ensure the adoption of these innovative devices in a safe and thoughtful manner.

Methods: We performed a retrospective review of data from 32 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed. The overall mean number of attempts and mean time to cannulation were used as target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures.

Results: Overall, 32 patients underwent ERCP using the disposable duodenoscope by a single experienced endoscopist (Table 1). 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 28 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). Procedure-related complications are described in Table 1. Number of attempts to cannulate the desired duct and time to cannulation are illustrated by CUSUM plots in Figure 1. In both endpoints, an inflection of the CUSUM curves is achieved at approximately 10 cases, indicating sustained shortening of cannulation attempts and time to cannulation.

Discussion: Among an experienced ERCP endoscopist, approximately 10 ERCPs can be considered the threshold to achieve proficiency with the use of a disposable duodenoscope. Procedure-related complications are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

Figure: Figure 1: Cumulative sum analysis (CUSUM) curves

Table 1. Patient demographics, procedural characteristics, outcomes and complications (n = 32)
Variable	n (%)^*
Demographic data
Mean age (years)	60 (31-84)^†
Female	14 (43)
Procedural characteristics
Native papilla	6 (19)
ASGE complexity level^‡ 1 2 3
	6 (19)
	15 (47)
	11 (34)
Procedural outcome
Technical success – procedure completion using disposable duodenoscope	28 (87)
Cases which required switching to a reusable duodenoscope	4 (13)
Procedural complications
Post-ERCP pancreatitis	1 (3)
Post-procedural abdominal pain	13 (46)^¶
Intra-procedural or post-procedural bleeding	1 (3)
Visceral perforation	0 (0)

*Values are n (%) unless otherwise specified
†Range
‡Based on the ASGE ERCP complexity scale (Gastrointest Endosc 2011;73:868-874)
¶10 patients had transient abdominal pain that resolved prior to discharge from the recovery room, while 3 patients required hospitalization for further management

Table: Table 1. Patient demographics, procedural characteristics, outcomes and complications

Disclosures:

Nasir Saleem indicated no relevant financial relationships.

Yan Tong indicated no relevant financial relationships.

Stuart Sherman: Boston Scientific – Consultant.

Mark Gromski: boston scientific – Consultant.

Nasir Saleem, MD¹, Yan Tong, PhD², Stuart Sherman, MD¹, Mark A. Gromski, MD¹. B0458 - Assessment of the Learning Curve for Single-Use Disposable Duodenoscope for a Single Operator, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.