Losartan to prevent hyperenzymemia after endoscopic retrograde cholangiopan-creatography: A randomized clinical trial

Table 1 Characteristics of the 76 participating patients and indications for their endoscopic retrograde cholangiopancreatography n (%)

Characteristic	Losartan group	Placebo group
Total	38 (100)	38 (100)
Study centre
Karolinska	19 (50)	19 (50)
Kalmar	19 (50)	19 (50)
Sex
Male	22 (58)	16 (42)
Female	16 (42)	22 (58)
Age, yr
< 65	13 (34)	14 (37)
≥ 65	25 (66)	24 (63)
Body mass index, kg/m2
< 20	3 (8)	2 (5)
20-25	14 (37)	14 (37)
> 25	7 (18)	9 (24)
Unknown	14 (37)	13 (34)
Previous pancreatitis
No	34 (89)	35 (92)
Yes	4 (11)	3 (8)
Indication for ERCP1
Jaundice without cholangitis	20 (53)	21 (55)
Jaundice with cholangitis	7 (18)	9 (24)
Suspected tumour in pancreas or bile ducts	10 (26)	13 (34)
Suspected benign disease, i.e., biliary lithiasis, stricture or other disease	20 (53)	16 (42)

¹Since each procedure could have several indications, the sum of percentages could be > 100. ECRP: Endoscopic retrograde cholangiopancreatography.

Table 2 Distribution of procedure-related findings at endoscopic retrograde cholangiopancreatography in the 76 participating patients n (%)

Finding/procedure1	Losartan group	Placebo group
Total	38 (100)	38 (100)
Cannulation of the common bile duct
Cannulation difficulty2
Easy or medium	27 (71)	27 (71)
Difficult or failed	10 (26)	9 (24)
Pancreatography
Number of pancreatic duct injections2
None	21 (55)	24 (63)
1-3	15 (39)	11 (29)
≥ 4	1 (3)	2 (5)
Extent of pancreatography2
None	21 (55)	24 (63)
Main duct	12 (31)	11 (29)
First branch, second branch, and acinarisation	4 (11)	2 (5)
Procedure-related findings in bile ducts2
Normal	5 (13)	3 (8)
Gallstone	13 (34)	14 (37)
Suspected cancer	6 (16)	8 (21)
Dilatation, benign or undetermined stricture, or anomaly	14 (37)	10 (26)
Procedure-related findings in pancreas2
Not contrast-fille	21 (55)	24 (63)
Normal	13 (34)	10 (26)
Suspected cancer	0 (0)	1 (3)
Dilatation	3 (8)	1 (3)
Endoscopic procedure
Biliary sphincterotomy
No	11 (29)	14 (37)
Yes	27 (71)	24 (63)
Biliary stenting
No	24 (63)	23 (61)
Yes	14 (37)	15 (39)
ERCP time, min2
< 30	13 (34)	10 (26)
≥ 30	22 (58)	26 (68)
Time between intake of losartan or placebo capsule and ERCP, min
< 60	9 (24)	7 (18)
≥ 60	29 (76)	31 (82)

¹The endoscopist assessed degree of technical difficulty;

²The total number of participants was 38 patients in each variable, and a sum < 38 indicate missing values between n = 2-5. ECRP: Endoscopic retrograde cholangiopancreatography.

Table 3 Serum pancreatic enzyme levels, abdominal pain, and pancreatitis after endoscopic retrograde cholangiopancreatography among 76 participating patients¹n (%)

Pancreatic enzyme level in serum	Losartan group	Placebo group	P value
Amylase (microkat/L), median, (interquartile range)
At baseline	0.44 (0.3)	0.46 (0.4)	0.64
4 h after ERCP	0.75 (2.5)	0.68 (1.0)	0.81
24 h after ERCP	0.62 (2.3)	0.82 (1.0)	0.33
Hyperamylasemia2 24 h after ERCP, number (%)	8 (24)	4 (13)	0.53
Missing data	5 (13)	6 (16)
Lipase (microkat/L), median, (interquartile range)
At baseline	0.53 (0.3)	0.48 (0.5)	0.47
4 h after ERCP	1.02 (5.9)	0.76 (1.4)	0.47
24 h after ERCP	0.77 (1.1)	1.07 (1.5)	0.62
Hyperlipasemia2 24 h after ERCP, number (%)	8 (21)	7 (18)	0.89
Missing data	5 (13)	7 (18)
Hyperenzymemia3 24 h after ERCP, number (%)	9 (24)	7 (18)	0.51
Missing data	4 (11)	3 (8)
Abdominal pain 24 h after ERCP, number (%)	8 (23)	9 (26)	0.93
Missing data	3 (8)	3 (8)
Acute pancreatitis (hyperenzymemia and abdominal pain after 24 h), number (%)	5 (13)	4 (11)	0.57
Missing data	7 (18)	4 (11)

¹In all analyses missing values were included as a separate category; P-values refer to overall differences between groups;

²Defined as 3 times higher than the normal reference value;

³Occurrence of hyperamylasemia or hyperlipasemia. ECRP: Endoscopic retrograde cholangiopancreatography.