What Is the Value of the Learning Curve in Endoscopic Balloon Dilatation of the Major Papilla?
Table 3
(a) Factors associated with success, adverse events, and severity. Univariate analysis
Success (%)
value
Adverse events (%)
value
Proportion of severe adverse events (%)
value
Age (<74.3 versus ≥74.3)
78.3/84.7
0.32
15.9/16
0.9
9.1/19
0.07
Sex (male/female)
84.7/80.4
0.57
15.3/16.7
0.81
20/11.8
0.72
INR (<1.03 versus ≥1.03)
81.3/85.5
0.8
15.8/14.5
0.34
13.6/25
0.49
Bilirubin (<3.05 versus ≥3.05)
83.1/79.2
0.13
16.2/15.1
0.94
21.7/0
0.99
Alkaline phosphatase (<307 versus ≥307)
79.6/86.6
0.62
11.1/23.9
0.08
8.3/18.8
0.3
GGT (<517 versus ≥517)
84.9/79.1
0.13
11.3/23.9
0.11
16.7/12.5
0.12
ASA classification (1/2/3/4)
66.7/85.9/85.2/79.2
0.18
20.8/15.5/13.6/20.8
0.75
0/18.2/27.3/0
0.3
PAD (yes/no)
85.3/81.9
0.61
14.7/16.3
0.85
0/18.5
0.48
Billroth-II gastrectomy (yes/no)
87.5/82.3
0.69
37.5/15.1
0.08
33.3/13.8
0.56
ERCP indication (cholangitis versus others)
88.1/79.7
0.56
11.9/18
0.51
40/4.5
0.12
≥2 stones (yes/no)
81.7/82.9
0.43
16.9/15.5
0.48
33.3/5
0.09
Size of stones (<13.5 versus ≥13.5 mm)
91.5/71.9
<0.001
17/14.6
0.51
6.2/23.1
0.04
CBD diameter (<14.1 versus ≥14.1 mm)
91.2/72.6
<0.001
13.2/16.4
0.4
16.7/8.3
0.63
Dilation diameter (<14.1 versus ≥14.1 mm)
88.5/78.7
0.07
12.8/18
0.34
0/22.7
0.19
EST (same time) (yes/no)
80.3/88.5
0.3
16.3/15.4
0.86
8.3/37.5
0.05
Previous EST (yes/no)
89.3/79
0.1
14.7/16.9
0.67
27.3/9.5
0.2
Previous EPLBD (yes/no)
83.3/82.4
0.92
16.7/16
0.92
0/16.7
0.48
Need for ML (yes/no)
46.2/85
<0.001
7.7/16.6
0.4
0/16.1
0.7
Precut EST (yes/no)
77.8/82.7
0.71
22.2/15.7
0.58
50/13.3
0.33
ERCP difficulty (1/2/3/4)
100/92/79/80
0.19
0/16/15.9/2
0.95
0/0/18.2/5
0.18
INR: international normalized ratio; GGT: gamma glutamil transpeptidase; ASA: American Society of Anaesthesiologists; CBD: common bile duct; EST: endoscopical sphincterotomy; EPLBD: endoscopic papillary large balloon dilatation; ML: mechanical lithotripsy; PAD: periampullary diverticulum.
(b) Outcomes depending on each endoscopist
Total
Endoscopist number 1
Endoscopist number 2
Endoscopist number 3
Endoscopist number 4
Endoscopist number 5
value
Number of EPLBD
200
42
29
70
39
20
Success (EPLBD 1st session)
165/200 (82.5%)
30/42 (71.4%)
27/29 (93.1%)
63/70 (90%)
31/39 (79.5%)
14/20 (70%)
0.03
Adverse events (EPLBD 1st session)
32/200 (16%)
7/42 (16.7%)
6/29 (20.7%)
11/70 (15.7%)
6/39 (15.4%)
2/20 (10%)
0.9
EPLBD: endoscopic papillary large balloon dilatation.
(c) Factors associated with technical success, complications, and their severity. Multivariate analysis
OR
95% CI
Technical success
Need for ML
0.19
0.04–0.81
0.03
Size of stones (<13.5/≥13.5 mm)
4.31
1.49–14.2
0.01
CBD diameter (<14.1/≥14.1 mm)
1.98
0.76–5.35
0.17
Dilation diameter (<14.1/≥14.1 mm)
0.94
0.27–3.34
0.93
Endoscopists 2 and 3
0.48
0.17–1.36
0.16
Incidence of adverse events
Endoscopists 2 and 3
0.99
0.30–2.80
0.91
Billroth-II gastrectomy
2.14
0.39–10.13
0.34
Platelet count
0.39
0.15–0.94
0.04
Alkaline phosphatase
0.48
0.20–1.13
0.09
Severe adverse events
Age > 74.3
0.9
0.008–82.9
0.96
>2 stones
0.07
0.001–1.03
0.09
Size of stones (<13.5/≥13.5 mm)
9.46
0.26–4224.83
0.31
EST (same time)
8.64
0.41–450.42
0.18
ML: mechanical lithotripsy; CBD: common bile duct; GGT: gamma glutamil transpeptidase; EST: endoscopical sphincterotomy.
