Effect of precut sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis

Table 1 Quality analysis of included randomized trials

Study	Year	Center	Country	Type of RCT	Allocation concealment	Intention to-treat	Jadad score
Cennamo et al[13]	2009	Single	Italy	Non blinded	A	Yes	3
Tang et al[15]	2005	Single	Canada	Non blinded	A	Yes	3
Khatibian et al[14]	2008	Single	Iran	Non blinded	B	Yes	3
de Weerth et al[12]	2006	Single	Germany	Non blinded	B	Yes	3
Zhou et al[11]	2006	Single	China	Non blinded	B	N/A	2
Manes et al[10]	2009	Multi	Italy	Non blinded	A	Yes	3
Swan et al[16]	2013	Single	Australia	Non blinded	A	N/A	2

Allocation concealment: A: Adequate; B: Unclear; N/A: Data not available; RCT: Randomized controlled trail.

Table 2 Baseline patient characteristics of included trials

Study	Patients (n)		Age (year in mean)		Female		Malignant jaundice		CBD stone		SOD
	E	Std	E	Std	E	Std	E	Std	E	Std	E	Std
Cennamo et al[13]	36	110	681	711	55.5%	53.6%	33.3%	25.4%	66.6%	74.5%	0	0
Tang et al[15]	32	30	64.6	67.2	53.1%	53.3%	34.3%	33.3%	21.9%	13.3%	3.1%	6.7%
Khatibian et al[14]	106	112	56.6	55.9	53.8%	67%	N/A	N/A	51.9%	68.8%	21.2%	12.8%
de Weerth et al[12]	145	146	66	64	66%	66%	40%	23%	46.8%	59.5%	N/A	N/A
Zhou et al[11]	43	48	62.7	64.3	39.5%	39.5%	30.2%	25%	20.9%	22.9%	N/A	N/A
Manes et al[10]	77	74	66	65	35%	35.1%	33.7%	40.5%	53.2%	41.9%	0	2.7%
Swan et al[16]	39	34	59	57	72%	66%	N/A	N/A	10.3%	17.6%	5.1%	8.8%

¹Age in median year. E: Early pre cut; Std: Standard method of cannulation; N/A: Data not available; CBD: Common bile duct; SOD: Sphincter of oddi dysfunction.

Table 3 Interventions in various trials and pancreatitis definitions

Study	Precut timing	Timing for std cannulation	Type of pre cut	Use of GW	PD stent/PP	PEP criteria	Fellow involvement
Cennamo et al[13]	5 min of failed cannulation or 3 pancreatic duct cannulation	20 min post randomization	Papillotomy	Yes	No	Consensus	No
						Criteria
Tang et al[15]	12 min of failed cannulation	15 min post randomization	Papillotomy	No	No	Consensus	Yes
						Criteria
Khatibian et al[14]	Immediate precut	15 min post randomization	Fistulotomy	Yes	No	Consensus	No
						Criteria
de Weerth et al[12]	Immediate precut	20 min post randomization or 3 pancreatic cannulation	Papillotomy	Yes	N/A	Consensus	No
						Criteria
Zhou et al[11]	10 min of failed cannulation or 3 pancreatic duct cannulation	N/A	Papillotomy and fistulotomy	Yes	N/A	N/A	N/A
Manes et al[10]	10 min of failed cannulation or 5 pancreatic duct cannulation	10 min post randomization	Fistulotomy	Yes	No	Consensus	N/A
						Criteria
Swan et al[16]	5 min of failed cannulation or 2 pancreatic duct cannulation	10 min post randomization	Papillotomy	Yes	Yes1	Consensus	Yes
						Criteria

¹Subjects with inadvertent PD cannulation. GW: Guidewire; PP: Pharmacological prophylaxis for post ERCP pancreatitis; N/A: Data not available; PD: Pancreatic duct; PEP: Post ERCP pancreatitis; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 4 Outcome of various studies

Study	Primary cannulation rates		ITT		Overall complication		Pancreatitis		Cholangitis		Bleeding		Perforation		Need for second ERCP
	E	Std	E	Std	E	Std	E	Std	E	Std	E	Std	E	Std	E	Std
Cennamo et al[13]	33/36	104/110	36/36	110/110	3/36	7/110	1/36	6/110	N/A	N/A	1/36	1/110	1/36	0/110	3/36	6/110
Tang et al[15]	24/32	22/30	31/32	28/30	4/32	3/30	2/32	2/30	1/32	0/30	1/32	0/30	0/32	0/30	0/32	1/30
Khatibian et al[14]	88/106	100/112	105/106	111/112	3/106	3/112	2/106	3/112	0/106	0/112	0/106	0/112	1/106	0/112	18/106	12/112
de Weerth et al[12]	145/145	145/146	145/145	146/146	3/145	5/146	3/145	4/146	N/A	N/A	0/145	1/146	0/145	0/146	0/145	1/146
Zhou et al[11]	39/43	36/48	N/A	N/A	4/43	7/48	1/43	2/48	0/43	2/48	1/43	0/48	0/43	0/48	N/A	N/A
Manes et al[10]	63/77	66/74	71/77	71/74	11/77	16/74	2/77	11/74	N/A	N/A	5/77	2/74	0/74	1/77	14/77	8/74
Swan et al[16]	34/39	29/34	N/A	N/A	9/39	8/34	8/39	6/34	N/A	N/A	1/39	2/34	0/39	0/34	N/A	N/A

E: Early pre cut; Std: Standard method of cannulation; N/A: Data not available; ITT: Intention to treat; ERCP: Endoscopic retrograde cholangiopancreatography.

Table 5 Subgroup and cumulative analysis for timing of precut sphincterotomy

Timing of precut	OR	Pvalue
Subgroup analysis
Immediate	0.73; 95%CI: 0.23-2.33	0.59
5-10 min	0.49; 95%CI: 0.23-1.04	0.07
5-12 min	0.53; 95%CI: 0.26-1.07	0.08
Cumulative analysis
Immediate	0.73; 95%CI: 0.23-2.33	0.59
Immediate and within 5 min	0.85; 95%CI: 0.40-1.80	0.67
Immediate and within 10 min	0.55; 95%CI: 0.29-1.03	0.06

Table 6 Odd’s ratio for outcomes

Outcomes	OR	Pvalue
Methods of precut
Fistulotomy	0.27; 95%CI: 0.09-0.82	0.02
Papillotomy	0.89; 95%CI: 0.41-1.92	0.77
Study quality
High quality study	0.44; 95%CI: 0.21-0.93	0.03
Sample size > 100	0.39; 95%CI: 0.17-0.89	0.02

Table 7 Summary of non-randomized studies

Study (lead author/year)	Country	Publication type	Mean age	Females	Pre cut application	n	Pancreatitis		P
							EP Std methods
Giussani et al[17], 2008	Italy	Abstract	N/A	N/A	< 10 cannulation attempts	804	8.3%	11.6%	NS
Testoni et al[18], 2010	Italy	Article	N/A	50.20%	< 10 cannulation attempts	308	7.6%	15.4%	NS
Xinopoulos et al[19], 2009	N/A	Abstract	N/A	N/A	N/A	134	8.3%	8.5%	NS
Madacsy et al[20], 2009	Hungary	Article	57	91%	10 min of failed cannulation or 5 pancreatic duct cannulation	57	0%	42.8%	< 0.05
Ayoubi et al[21], 2009	Italy	Abstract	68.6 (median)	58.9%	Immediate precut	173	1.1%	5.8%	NS
De La Mora-Levy et al[22], 2011	Mexico	Abstract	N/A	N/A	Immediate precut	68	10.3%	10.2%	NS
Testoni et al[23], 2011	Italy	Article	N/A	49.7%	< 10 cannulation attempts	2004	3.3%	14.3%	< 0.05

N/A: Data not available; NS: Non significant; EP: Early pre cut; Std: Standard method of cannulation.