Comparison between needle-knife fistulotomy and standard cannulation in ERCP

Table 1 Characteristics of patients

	Group F	Group S	P value
No. of patients	88	85
Sex (male/female)	48/40	47/38	NS
Mean age (yr)	68 (36–93)	70 (32–96)	NS1
Diagnosis
Choledocholithiasis	58	59
Malignant stenosis	20	17
Benign stenosis	6	8
Postoperative leak	2	1
Scleroses cholangitis	1	0
Mirizzi’s syndrome	1	0

¹Evaluation of statistical significance according to Student t test for unpaired data. Evaluation of statistical significance according to χ² test. NS: Not significant.

Table 2 Complication rate n (%)

Adverse effect	Group F 12/88 (13.6)	Group S 15/85 (17.6)	P value
Hyperamilasemia	7 (7.9)	7 (8.2)	NS
Mild pancreatitis	1 (1.1)	5 (5.8)	NS
Minor bleeding	2 (2.27)	2 (2.35)	NS
Major bleeding	1 (1.13)	1 (1.17)	NS
Death	0	1 (1.17)	NS

Evaluation of statistical significance according to χ² test. NS: Not significant.

Table 3 Deep biliary cannulation success rate

	Group F	Group S	P value
During the first ERCP	85/88 (96.5%)	60/85 (70.6%) (within 4 attempts of no more than 5 min)	< 0.0001
		Patients shifted to fistulotomy 21/24 (84%)
During the second ERCP after 7 d	0	4 (4.7%)
Overall success rate	96.5%	98.8%

Evaluation of statistical significance according to χ² test. ERCP: Endoscopic retrograde cannulation of the papilla; NS: Not significant.