Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography

Table 1 Patient characteristics

	Non-stent	Stent	P value
No. of patients	60	60	-
Mean age (range) (yr)	68 (27-92)	66 (24-88)	0.35
Sex: female/male	25/35	27/33	0.46
Reasons of high risk
Previous post-ERCP pancreatitis	5 (8%)	5 (8%)	0.65
Sphincter of Oddi dysfunction	0 (0%)	0 (0%)	-
A difficult cannulation	10 (17%)	10 (17%)	0.68
Pre-cut	0 (0%)	0 (0%)	-
Pancreatic sphincterotomy	5 (8%)	4 (7%)	1
Pancreatic duct biopsy	5 (8%)	6 (10%)	1
IDUS for pancreatic duct	27 (45%)	25 (42%)	0.15
Procedure time greater than 30 min	29 (48%)	33 (55%)	0.50

ERCP: Endoscopic retrograde cholangiopancreatography; IDUS: Intraductal ultrasonography.

Table 2 Final diagnosis n (%)

	Non-stent	Stent	P value
Biliary disease
CBD stone	16 (27)	15 (25)	0.68
Cholangitis	2 (3)	2 (3)	0.49
Cholangiocarcinoma	4 (7)	3 (5)	1
Cholangiocellular carcinoma	2 (3)	1 (2)	1
Benign biliary stricture	1 (2)	2 (3)	1
Primary sclerosing cholangitis	2 (3)	1 (2)	1
GB stone	1 (2)	0 (0)	1
GB polyp	1 (2)	1 (2)	1
GB adenomyomatosis	1 (2)	1 (2)	0.46
Cholecystitis	1 (2)	1 (2)	0.46
GB carcinoma	3 (5)	3 (5)	0.47
Pancreatic disease
IPMN	10 (17)	11 (18)	0.67
MCN	0 (0)	1 (2)	1
SCN	1 (2)	0 (0)	1
Chronic pancreatitis	3 (5)	3 (5)	0.47
Pancreatic cyst	1 (2)	2 (3)	1
Pancreatic carcinoma	11 (18)	13 (22)	0.65

CBD: Common bile duct; GB: Gallbladder; IPMN: Intraductal papillary mucinous neoplasm; MCN: Mucinous cystic neoplasm; SCN: Serous cystic neoplasm.

Table 3 Placement of the pancreatic duct stent

No. of patients	60
Success rate in stent placement	100%
Rate of spontaneous stent dislodgement	96.7%
Duration time to dislodgement, d, (range)	2.1 (23)
Complications
Stent migration	0%
Post-ERCP pancreatitis	1.7%
Hyperamylasemia	30%
Hemorrhage	0%
Perforation	0%
Infection (cholangitis, cholecystitis)	0%
Others	0%
Mean serum amylase level after procedures, U/L, (range)	1246 (746-1964)

ERCP: Endoscopic retrograde cholangiopancreatography.

Table 4 Overall post-endoscopic retrograde cholangiopancreatography pancreatitis in non-stent and stent groups

	Non-stent	Stent	P value
No. of patients	60	60
Hyperamylasemia	23 (38.3%)	18 (30%)	0.862
Average serum amylase level (IU/L) (range)	842.4 (381-2040)	746.2 (420-1620)	0.798
Post-ERCP pancreatitis	8 (13.3%)	1 (1.7%)	0.0322
Mild	8	1	0.0322
Moderate	0	0	-
Severe	0	0	-
Average serum amylase level in pancreatitis cases (IU/L) (range)	1720 (820-2040)	1240 (746-1964)	0.04

ERCP: Endoscopic retrograde cholangiopancreatography. The Chi-square test or Fisher’s exact test was used to determine the significance of associations, and P < 0.05 was regarded as significant.

Table 5 Final diagnoses in post-endoscopic retrograde cholangiopancreatography pancreatitis patients

	Non-stent	Pancreatitis	Stent	Pancreatitis
Biliary disease
CBD stone	16	3 (19%)	15	0
Cholangitis	2	0	2	0
Cholangiocarcinoma	4	1 (25%)	3	0
Cholangiocellular carcinoma	2	0	1	0
Benign biliary stricture	1	0	2	0
Primary sclerosing cholangitis	2	0	1	0
GB stone	1	0	0	0
GB polyp	1	0	1	0
GB adenomyomatosis	1	0	1	0
Cholecystitis	1	0	1	0
GB carcinoma	3	1 (33%)	3	0
Pancreatic disease
IPMN	10	1 (10%)	11	0
MCN	0	0	1	0
SCN	1	0	0	0
Chronic pancreatitis	3	0	3	0
Pancreatic cyst	1	0	2	0
Pancreatic carcinoma	11	2 (18%)	13	1 (8%)

CBD: Common bile duct; GB: Gallbladder; IPMN: Intraductal papillary mucinous neoplasm; MCN: Mucinous cystic neoplasm; SCN: Serous cystic neoplasm.

Table 6 Analysis of risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis n (%)

	Non-stent	Pancreatitis	Stent	Pancreatitis	Univariate P value
No. of patients	60	8	60	1
Age (< 60 yr)	17 (28)	3 (18)	18 (30)	0 (0)	0.72
Female	25 (42)	3 (12)	27 (45)	0 (0)	0.78
Previous post-ERCP pancreatitis	5 (8)	1 (20)	5 (8)	0 (0)	0.68
Sphincter of Oddi dysfunction	0 (0)	0 (0)	0 (0)	0 (0)	-
A difficult cannulation	10 (17)	2 (20)	10 (17)	0 (0)	0.68
Pre-cut	0 (0)	0 (0)	0 (0)	0 (0)	-
Pancreatic sphincterotomy	5 (8)	1 (20)	4 (7)	0 (0)	0.68
Pancreatic duct biopsy	5 (8)	1 (20)	6 (10)	1 (17)	0.87
IDUS for pancreatic duct	27 (45)	3 (11)	25 (42)	1 (4)	0.74
Procedure time greater than 30 min	29 (48)	4 (14)	33 (55)	0 (0)	0.72

ERCP: Endoscopic retrograde cholangiopancreatography; IDUS: Intraductal ultrasonography.