Outcomes of bile duct cannulation using a novel contrast-enhanced catheter: A single-center, retrospective cohort study

Table 1 Baseline characteristics of the existing and novel catheter groups, n (%)

Character	Existing catheter group (n = 230)	Novel catheter group (n = 112)	P value
Age median (range)	77 (29-97)	80.5 (44-104)	0.84
Sex (male/female)	144/96	56/56	0.874
Primary disease
Benign disease	147 (63.9)	73 (65.1)	-
Bile duct stones	134 (58.2)	66 (58.9)	-
Benign bile duct stricture	6 (2.6)	2 (1.8)	-
Other (benign)	7 (3.0)	5 (4.5)	-
Malignant disease	83 (36.1)	39 (34.8)	-
Pancreatic cancer	33 (14.3)	16 (14.2)	-
Cholangiocarcinoma	46 (20.0)	22 (19.6)	-
Other (malignant)	4 (1.7)	1 (0.9)	-
Benign/malignant disease	147/83	73/39	0.90
Parapapillary diverticular papilla	60 (26.1)	27 (24.1)	0.79
Oral protrusion-large	60 (26.1)	28 (25.0)	0.90
Expert/non-expert	115/115	64/48	0.25

Table 2 Overall outcomes for each group, n (%)

Character	Existing catheter group (n = 230)	Novel catheter group (n = 112)	P value
Cannulation success rate	98.3% (226/230)	99.1% (111/112)	0.47
Number of attempts of cannulation, median (range)	3 (1-20)	3 (1-10)	0.58
Difficult cannulation (> 5 times)	94 (40.9)	36 (32.1)	0.074
Cannulation success rate with the standard technique	73.0% (168/230)	82.1% (92/112)	0.042
Rescue technique
Switch to sphincterotomes	8 (3.5)	0	0.039
Pancreatic duct GW method	14 (6.1)	2 (1.8)	0.059
Precut	35 (15.2)	17 (15.3)	0.56
Two devices in one channel method	1 (0.4)	0	0.67
Cannulation failure	4 (1.7)	1 (0.9)	0.47
Re-ERCP	1 (0.4)	0	0.67
EUS-HGS	2 (0.9)	1 (0.9)	0.70
EUS-rendezvous	1 (0.4)	0	0.67
Adverse event
Total	12 (5.2)	5 (4.5)	0.70
Bleeding	2 (0.9)	2 (1.8)	0.60
PEP	10 (4.3)	3 (2.7)	0.59
Mild	9 (3.9)	2 (1.8)	0.51
Moderate disease	1 (0.4)	1 (0.9)	0.55
Severe disease	0	0	-

GW: Guide wire; ERCP: Endoscopic retrograde cholangiopancreatography; EUS: Endoscopic ultrasound; EUS-HGS: Endoscopic ultrasound-guided hepaticogastrostomy; EUS-rendezvous: Endoscopic ultrasound-guided rendezvous technique; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.

Table 3 Outcomes for each group when a non-expert is the practitioner, n (%)

Character	Existing catheter group (n = 115)	Novel catheter group (n = 48)	P value
Cannulation success rate	99.1% (114/115)	100% (48/48)	0.71
Number of attempts of cannulation median (range)	4.5 (1-20)	5 (1-10)	0.67
Difficult cannulation (> 5 times)	56 (48.7)	25 (52.1)	0.73
Cannulation success rate with the standard technique	79.1% (91/115)	83.3% (40/48)	0.66
Rescue technique
Switch to sphincterotomes	2 (1.7)	0	0.47
Pancreatic duct GW method	5 (4.3)	1 (2.1)	0.67
Precut	13 (11.3)	7 (14.6)	0.60
Two devices in one channel method	1 (0.9)	0	0.69
Cannulation failure	1 (0.9)	0	0.69
Re-ERCP	0	0	-
EUS-HGS	1 (0.9)	0	0.69
EUS-rendezvous	0	0	-
Adverse event
Total	4 (3.5)	3 (6.3)	0.50
Bleeding	1 (0.9)	2 (4.2)	0.21
PEP	3 (2.6)	1 (2.1)	0.66
Mild disease	3 (2.6)	1 (2.1)	0.66
Moderate disease	0	0	-
Severe disease	0	0	-

GW: Guide wire; ERCP: Endoscopic retrograde cholangiopancreatography; EUS: Endoscopic ultrasound; EUS-HGS: Endoscopic ultrasound-guided hepaticogastrostomy; EUS-rendezvous: Endoscopic ultrasound-guided rendezvous technique; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.

Table 4 Outcome of each group when an expert is the practitioner, n (%)

Character	Existing catheter group (n = 115)	Novel catheter group (n = 64)	P value
Cannulation success rate	97.3% (112/115)	98.4% (63/64)	0.55
Number of attempts of cannulation median (range)	2 (1-18)	2 (1-10)	0.67
Difficult cannulation (> 5 times)	37 (32.1)	11 (17.2)	0.021
Cannulation success rate with the standard technique	65.2% (75/115)	81.3% (52/64)	0.017
Rescue technique
Switch to sphincterotomes	6 (5.2)	0	0.067
Pancreatic duct GW method	9 (7.8)	1.6% (1/64)	0.073
Precut	22 (19.1)	15.6% (10/64)	0.36
Two devices in one channel method	0	0	-
Cannulation failure	3 (2.7)	1 (1.6)	0.55
Re-ERCP	1 (0.9)	0	0.64
EUS-HGS	1(0.9)	1 (1.6)	0.59
EUS-rendezvous	1 (0.9)	0	0.64
Adverse event
Total	8 (7.0)	2 (3.1)	0.24
Bleeding	1 (0.9)	0	0.64
PEP	7 (6.1)	2 (3.1)	0.31
Mild disease	6 (5.2)	1 (1.6)	0.39
Moderate disease	1 (0.9)	1 (1.6)	0.64
Severe disease	0	0	-

GW: Guide wire; ERCP: Endoscopic retrograde cholangiopancreatography; EUS: Endoscopic ultrasound; EUS-HGS: Endoscopic ultrasound-guided hepaticogastrostomy; EUS-rendezvous: Endoscopic ultrasound-guided rendezvous technique; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.