Table 1. Baseline Patient Characteristics.

Characteristic	Indomethacin (n=223)	Placebo (n=226)	P value
Age – yr	64.9	64.3	0.68
Female Sex – no. (%)	118 (52.9)	118 (52.2)	0.92
Indication – no. (%)
Acute Cholangitis	12 (5.4)	13 (5.8)	1.00
Choledocholithiasis	59 (26.4)	52 (23.0)	0.44
Malignant Biliary Obstruction*	53 (23.8)	50 (22.1)	0.74
Biliary Stent Change	25 (11.2)	25 (11.1)	1.00
Biliary Leak	11 (4.9)	12 (5.3)	1.00
Elevated Liver Tests/Jaundice	13 (5.8)	9 (4.0)	0.39
Pancreatic Stricture	3 (1.3)	5 (2.2)	0.72
Suspected Sphincter of Oddi Dysfunction	6 (2.7)	8 (3.5)	0.79
Pancreatic Leak/Disruption	11 (4.9)	12 (5.3)	1.00
Pancreatic Duct Stone	3 (1.3)	2 (0.9)	0.68
Recurrent Acute Pancreatitis	5 (2.2)	2 (0.9)	0.28
Ampullectomy	6 (2.7)	5 (2.2)	0.77
Other†	16 (7.2)	31 (13.7)	0.03
History of post-ERCP pancreatitis – no. (%)	9 (4.0)	9 (4.0)	1.00
Previous Sphincterotomy – no. (%)	72 (31.8)	71 (31.4)	0.61
Previous ERCP – no. (%)	81 (36.3)	79 (35.0)	0.77

^*Malignant biliary obstruction includes pancreatic head malignancy, cholangiocarcinoma and indeterminate biliary stricture

^†Most common indications for “other” included primary sclerosing cholangitis, papillary stenosis, and choledochal cyst evaluation