Introduction
Digestive endoscopes are reprocessed after each procedure through a high-level disinfection
process to decrease risk of cross-contamination and, therefore, risk of infection
in subsequent patients [1]
[2]. Because of their particular design, duodenoscopes are particularly prone to contamination
[1]
[3], and presence of microorganisms of concern has been found in up to 15 % of reusable
duodenoscopes on systematic sampling [2]. In this context, single-use duodenoscopes (SUDs) recently have been developed as
an alternative to scope reprocessing. The usefulness and effectiveness of SUDs has
been the subject of a few publications [4]
[5]
[6]
[7]
[8]
[9]
[10]
[11], including a randomized trial showing equivalent performance for SUDs and reusable
duodenoscopes and similar success on low-complexity procedures [4]. Endoscopic retrograde cholangiopancreatography (ERCP), which requires a duodenoscope,
is the gold standard procedure for biliary emergencies such as acute cholangitis,
urgent biliary drainage or post-sphincterotomy bleeding [3]
[4]
[11]. However, the availability of regular duodenoscopes can be limited at night or during
weekends, when cleaning and reprocessing staff and material are unavailable or in
a short supply. While few studies have reported that even complex procedures can be
performed by using SUDs [8]
[10], the effectiveness of those devices in the specific context of emergency ERCP remains
to be assessed. Our objective was to report the efficiency of SUDs for ERCP emergencies
in a real-life setting, when a reusable duodenoscope backup is unavailable.
Patients and methods
Background, inclusion and exclusion criteria, outcome measure definitions
We conducted a prospective consecutive case series of SUD-based procedures involving
seven endoscopists in a tertiary care center (Beaujon Hospital). In July 2021, construction
in the endoscopy unit precluded storage and reprocessing of our regular (reusable)
duodenoscopes for 3 consecutive weeks. This situation forced us to perform emergency
ERCPs using SUDs. Endoscopic ultrasound and diagnostic colonoscopy were unavailable
during that same period, but upper gastrointestinal endoscopy remained possible on
an emergency-only inpatient basis.
Biliary emergencies were defined as: 1) acute cholangitis with severe sepsis or persistent
septicemia more than 24 hours after beginning of antibiotherapy; 2) acute biliary
pancreatitis with an impacted intra-ampullary stone requiring extraction; 3) severe
jaundice (> 250 mmol/L) with intractable pruritus and impaired nutritional status;
and 4) active hemobilia or post-sphincterotomy bleeding [12]. Patients presenting with other indications for ERCP had their endoscopy postponed
until after the full reopening of the unit.
This was a retrospective study on prospective data relating to routine care. According
to current French legislation, the data used were anonymized and collected in a database
with notice to the Commission Nationale Informatique et Liberté (n°2224486). Moreover,
all endoscopies were performed in an emergency after informed consent was received
from the patient or a patient-approved third party.
Seven endoscopists participated with different levels of experience: two were novices
with less than 2 years of experience and performing mentored-only ERCP, two were experts
with more than 15 years of practice, while the three others had 5 to 10 years of experience.
Procedures were graded according to their expected difficulty using the American Society
for Gastrointestinal Endoscopy (ASGE) grading scale [13].
The main outcome measure was the ERCP success rate, defined as successful achievement
of the intended procedure (eg sphincterotomy and complete stone clearance, adequate
biliary stricture stenting with complete biliary drainage, effective hemostasis of
an active bleeding). Outcome was rated as a partial success in case of incomplete
stone extraction or biliary drainage. Secondary outcomes were SUD technical performance
as prospectively assessed by operators and nurses.
Device
The duodenoscope used in this study was the sterile, disposable EXALT model D (Boston
Scientific, Marlborough, Massachusetts, United States) endoscope. A member of the
commercial staff from the supplier was present for training and to help nurses and
endoscopists during the first two ERCPs, but not thereafter.
Data
Data were collected at baseline and immediately after ERCP in an anonymous database,
including operator experience and previous nurse training, procedure efficiency (technical
success), device handling by medical and non-medical staff (cart/duodenoscope installation,
global functions and maneuvers, placement over papilla, cannulation), component functionality
(tube, knobs, elevator, working channel, etc.), image quality (color, contrast, sharpness,
identification of prespecified anatomic features), overall satisfaction (ratings by
medical and non-medical staff), and intra-procedure adverse events (AEs).
After each procedure, the endoscopist and nurse were asked to complete a form reporting
their assessment of duodenoscope functionality, completion of the exam, and any deficiency
encountered. No crossover was allowed, given the unavailability of regular duodenoscopes.
Results
Patient characteristics
Nineteen patients (mean age 49.5 ± 15 years) were enrolled in the study and 21 procedures
were performed using SUDs. Indications for emergent ERCP were: acute cholangitis (10
procedures, 48 %), severe jaundice (8 procedures, 38 %), acute biliary pancreatitis
with impacted stones (1 procedure, 5 %), hemobilia/post-endoscopic surgery bleeding
(2 procedures, 9 %). Fifteen ERCPs (79 % of patients, 71 % of procedures) were performed
on a native papilla. The main objective of the procedure was: endoscopic biliary sphincterotomy
(N = 8, 38 %), stone extraction (N = 2, 9.5 %), biliary stenting (plastic stenting
[N = 3, 14.5 %], metallic stenting [N = 10, 48 %], plastic stent exchange (N = 1,
5 %). and local hemostasis (N = 2, 9.5 %).
Main outcome
Of the 21 procedures, 19 (90 %) were a complete success, one (5 %) was considered
a partial success after a failure to remove a stone upstream of a common bile duct
(CBD) stricture, and one (5 %) was a failure (CBD intubation failure).
Details of ECRP procedures
Of the successful ERCPs, five (24 %) were achieved by the two novice operators ([Table 1]).
Table 1
ERCP details.
|
Indications
|
|
|
10 (48 %)
|
|
|
8 (38 %)
|
|
|
2 (9 %)
|
|
|
1 (5 %)
|
|
Success
|
|
|
19 (90 %)
|
|
|
1 (5 %)
|
|
|
1 (5 %)
|
|
ASGE grade
|
|
|
12 (57 %)
|
|
|
9 (43 %)
|
|
Characteristics of procedures
|
|
|
15 (71 %)
|
|
|
4 (19 %)
|
|
|
13 (62 %)
|
|
|
2 (10 %)
|
|
Highlights
|
|
|
2 (10 %)
|
|
|
1 (5 %)
|
|
|
5 (24 %)
|
ERCP, endoscopic retrograde cholangiopancreatography; ES, endoscopic surgery; ASGE,
American Society for Gastrointestinal Endoscopy.
Procedures were ASGE grade 1, 2, 3 and 4 in 14 %, 43 %, 29 % and 14 %, respectively.
Representative procedures included papillary cannulation (N = 19), biliary sphincterotomy
(N = 7) and infundibulotomy (N = 2), stone clearance (N = 5), balloon dilation of
strictures (N = 4), and removal and exchange of stents (N = 5). One patient underwent
a Spyglass cholangioscopy during the same procedure for intra-hepatic stone destruction
(Boston Scientific, Marlborough, Massachusetts, United States). Waste disposal of
the SUD was unproblematic in every situation encountered.
When asked to rate SUDs as compared to reusable duodenoscopes after each ERCP, the
respective operator deemed cannulation with SUD devices comparable in 73 % and inferior
in 27 % of cases, respectively.
Secondary outcomes
Not a single AE was encountered ([Fig. 1] and [Table 2]). Installation of SUDs was adequate and easy in 100 % of procedures.
Fig. 1 Endoscopic view of the single-use duodenoscope during a sphincterotomy with stone
extraction
Table 2
Device performance.
|
Papilla exposure
|
100 %
|
|
Cannulation comparable to the reusable duodenoscope DR
|
15 (71 %)
|
|
|
5 (24 %)
|
|
|
16 (76 %)
|
|
|
13 (62 %)
|
|
|
20 (95 %)
|
|
|
19 (90 %)
|
|
|
15 (71 %)
|
|
Image quality
|
|
|
3 (14 %)
|
|
|
10 (48 %)
|
|
|
8 (38 %)
|
|
|
4 (19 %)
|
The function of the SUDs was satisfactory, except for one on which the insufflation
button needed to be fixed. Introduction and progression of the SUD to the second duodenum
were found easy in 20 of 21 (95 %) and 19 of 21 (91 %) cases, respectively, but maneuvering
inside the duodenum was found tricky during two procedures. Device positioning over
the papilla was satisfactory in 17 of 21 cases (80 %). Scope position was graded as
stable in 15 of 21 cases (71 %). Shaft stiffness was considered a likely factor for
these minor inconveniences.
Maneuverability was deemed excellent by endoscopists for lateral and vertical directions
and overall grip in 13 of 21 (62%), 16 of 21 (76 %), and 16 of 21 procedures (76 %),
respectively. Concerning the elevator: pushability (such as for stent insertion) was
deemed excellent, correct, and average in 43 %, 52 %, and 5 % of procedures, respectively,
whereas elevator power was rated as excellent, correct, average, and underwhelming
in 14 %, 62 %, 19 %, and 5 % of procedures, respectively. On two different occasions,
the guidewire was not efficiently blocked by the elevator during over-the-wire exchanges.
Insufflation and aspiration were rated as excellent in 90 % and 71 % of procedures,
respectively.
Endoscopic imaging
Endoscopic vision was deemed correct in 86 % and subpar in 14% of procedures. The
main criticisms about vision concerned skewing of color dominance toward yellowish
tones (48 % of procedures), whereas blurred vision (14 %) and lack of contrast were
encountered in 19 % of cases. Image sharpness was considered excellent in 14 %, adequate
in 48 %, and with a substantial margin for improvement in 38 % of procedures, respectively.
In the case of post-sphincterotomy bleeding, the image was good quality.
Discussion
This report is the first to address SUDs exclusively for emergent situations in a
real-life setting and with no possibility of switching to a regular scope, a stressful
situation for operators in a suboptimal context. SUDs were shown to be satisfactory
and efficient overall and to be associated with a high rate of procedure completion,
similar to what would be expected with reusable duodenoscopes, although most operators
were not ERCP experts. All but one of the emergency ERCP procedures could be performed
with SUDs, which may justify the purchase of SUDs for overnight and weekend shifts,
for patients colonized with multidrug-resistant bacteria or in whomm Creutzfeld-Jakob
disease is suspected, as well as when logistical hurdles make reusable scopes unavailable
(ie repeat scope breakdowns) or preclude reprocessing (ie the situation reported in
this study). Finally, one can also imagine potential interest in SUD use when standard
devices are unavailable after hours.
However, this study also showed some limitations because the image was often considered
skewed toward yellow tones and pushability was an issue in a few procedures.
Although the limited, even marginal indications listed above should not be a matter
of serious environmental concern, expanded use of SUDs would certainly make waste
disposal and carbon footprint (including manufacturing, supply chains, medical use
and disposal) major issues. If use of this type of system becomes more widespread,
comparing the carbon footprint as well as the social impact of SUDs and reusable scopes
should be a priority [14]. In the meantime, it is probably necessary to clearly define the indications for
which SUDs should really be recommended in lieu of regular scopes.
Conclusions
This study showed that SUDs are safe and efficient devices, appropriate for emergent
situations in real life even in non-expert hands. This report contributes to defining
the place of SUDs in the therapeutic arsenal.
