Lactated Ringer’s solution in combination with indomethacin for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A prospective, randomized trial

Table 1 Baseline patient characteristics, n (%)

Characteristics		IND (n = 70)	LR (n = 70)	IND + LR (n = 70)	P value
Mean age (years)		60	63	61	0.44
Sex	Female	39 (55.71)	34 (48.57)	38 (57.28)	0.62
	Male	31 (44.28)	36 (51.42)	32 (45.71)	-
Mean risk score (number)		1.9	1.8	2	0.36
Female and age < 50 years		23 (32.85)	26 (37.14)	25 (35.71)	0.12
Normal total bilirubin (< 1 mg/dL)		29 (41.42)	32 (45.71)	34 (48.57)	0.09
History of post-endoscopic retrograde cholangiopancreatography pancreatitis		5 (7.1)	7 (1)	6 (8.5)	0.23
History of recurrent pancreatitis		2 (2.8)	1 (1.4)	2 (2.8)	0.72
Difficult cannulation (> 8 attempts)		11 (15.71)	14 (20.00)	16 (22.85)	0.14
Biliary sphincterotomy		52 (74.28)	46 (65.71)	49 (70.00)	0.23
Precut sphincterotomy		21 (30)	17 (24.28)	16 (22.85)	0.11
Plastic biliary stent		13 (18.57)	21 (30.00)	22 (31.42)	0.09
Self-expanding metal stent		2 (2.8)	1 (1.4)	1 (1.4)	0.61
Pancreatography		1 (1.4)	0 (0)	1 (1.4)	0.87
Pancreatic sphincterotomy		7 (10)	9 (12.85)	10 (14.28)	0.21
Pancreatic acinarization		2 (2.8)	4 (5.71)	3 (4.28)	0.31
Pancreatic duct stent placement		16 (22.85)	12 (17.14)	11 (15.71)	0.21

IND: Indomethacin; LR: Lactated Ringer’s solution.

Table 2 Primary and secondary study outcomes, n (%)

Outcomes	IND (n = 70)	LR (n = 70)	IND + LR (n = 70)	P value
PEP	7 (10.00)	12 (17.14)	4 (5.71)	1
Severe PEP	1 (1.4)	2 (2.8)	2 (2.8)	0.86
Pseudocyst	1 (1.4)	0 (0)	0 (0)	1.00
Pulmonary edema	1 (1.4)	1 (1.4)	0 (0)	0.92
Renal failure	1 (1.4)	1 (1.4)	0 (0)	0.93
Gastrointestinal bleeding	1 (1.4)	2 (2.8)	0 (0)	0.82
Anaphylaxis	0 (0)	0 (0)	0 (0)	0.98
Death	2 (2.8)	1 (1.4)	1 (1.4)	1.00
Readmission	5 (7.14)	7 (10)	2 (2.8)	1
Mean length of stay, days	3.40	4.70	3.12	0.12

¹Results in Figure 2.

IND: Indomethacin; LR: Lactated Ringer’s solution; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.