Efficacy and safety of single use duodenoscopes in comparison to reusable duodenoscopes for endoscopic retrograde cholangiopancreatography: A single center experience

Table 1 Baseline patients’ characteristics and endoscopic retrograde cholangiopancreatography details, n (%)

Characteristics	Total cohort (n = 133)	Single-use duodenoscope (n = 53)	Reusable duodenoscope (n = 80)	P value
Age (years), mean ± SD	69.54 ± 13.3	69.8 ± 12.4	68.9 ± 14.4	0.72
Gender (male, %)	53.3	56.6	51.3	0.59
Body mass index (kg/m2), mean ± SD	28.2 ± 7.9	30.5 ± 9.9	27.2 ± 6.3	0.07
Diabetes mellitus	32 (24)	16 (30.1)	16 (20)	0.2
Use of anti-coagulants	21 (15.7)	10 (18.8)	11 (13.7)	0.42
CCI score
Low, CCI = 0	13 (9.8)	2 (3.7)	11 (13)	0.23
Moderate, CCI = 1–2	50 (37.6)	18 (34)	32 (40)	0.71
High, CCI > 2	70 (52.6)	33 (62)	37 (47)	0.09
Indications for endoscopic retrograde cholangiopancreatography
Choledocholithiasis	41 (30.8)	18 (34)	23 (28.7)
Mass	16 (12)	6 (11.3)	10 (12.5)
Cholestatic liver injury	47 (35.3)	17 (32)	30 (37.5)
Stent exchange/removal	16 (12)	8 (15)	8 (10)
Others	13 (9.8)	4 (7.5)	9 (11.2)
American Society for Gastrointestinal Endoscopy grade				0.37
Grade 1, 2	106 (79.7)	44 (83.7)	62 (77.3)
Grade 3, 4	27 (20.3)	9 (16.3)	18 (22.7)
Mean total procedure time (minutes)	47.1	48.8	45.9	0.6

CCI: Charlson Comorbidity Index.

Table 2 Adverse events, n (%)

	Single-use duodenoscope	Reusable duodenoscope
Total	7 (13.2)	9 (11.2)
Post-endoscopic retrograde cholangiopancreatography pancreatitis	3 (5.6)	5 (6.2)
Post-sphincterotomy bleeding	2 (3.8)	2 (2.5)
Traumatic bleeding	1 (1.9)	1 (1.2)
Perforation	1 (1.9)	1 (1.2)

Traumatic bleeding refers to bleeding from direct duodenoscope traumatic injury to the mucosa.

Table 3 Operators’ ratings of single-use duodenoscope performance relative to the reusable duodenoscope per endoscopic retrograde cholangiopancreatography maneuvers

Maneuver	Preferred	Neutral	Not preferred
Biliary sphincterotomy	-	100% (5/5)	-
Cannulation of main bile duct	-	100% (5/5)	-
Cannulation of pancreatic duct	40% (2/5)	60% (3/5)	-
Clearance of bile duct stones	-	100% (5/5)	-
Placement of biliary stents	-	100% (5/5)	-
Removal of biliary stents	-	100% (5/5)	-
Placement of pancreatic stents	40% (2/5)	60% (3/5)	-
Balloon dilation of biliary strictures	-	100% (5/5)	-

Five is the total number of participating operators all of whom completed this rating.

Table 4 Median ratings for single-use duodenoscope performance characteristics

Performance characteristics	Median rating (range)
Ease and ability to intubate the esophagus	4 (1-5)
Ease and ability of traversing the stomach and the pylorus	4 (1-5)
Inadvertent slippage out of the duodenum	4 (1-5)
Navigation/pushability (overall from insertion to the deepest point of advancement into duodenum)	4 (1-5)
Predictability of range of motion	4 (1-5)
Suction performance	5 (1-5)
Ability to select short/long position as needed	4 (1-5)
Ease and ability to examine luminal mucosa where necessary	5 (1-5)
Stability of scope during cannulation of papilla	4 (1-5)
Elevator function	5 (1-5)
Ability to selectively cannulate	5 (1-5)
Tip control and deflection at time of cannulation	5 (1-5)
Ease of controlling and maintaining position during sphincterotomy	5 (1-5)
Position of the device in the field of view	5 (1-5)
Visualization/location of important landmarks on monitor	4 (1-5)
Maintenance of grip on wire by elevator	5 (1-5)
Elevator strength and ability to pass rigid device into common bile duct or pancreatic duct	5 (1-5)
Torquability of scope and ability to orient tip of scope in direction of push/pull	4 (1-5)
Ease and ability of passing/advancing ancillary devices through the channel of single use duodenoscope	5 (1-5)
Image quality/appearance/brightness	4 (1-5)
Ease and ability of duodenoscope withdrawal	4 (1-5)
Overall satisfaction	8 (1-10)