The diagnostic value of bile salt-dependent lipase for pancreatic dise
ases was tested in sera of 187 patients. Of these patients, 76 suffere
d from pancreatic carcinoma, 43 from nonmalignant liver diseases (cirr
hosis and chronic hepatitis), 18 from acute pancreatitis, and 20 from
chronic pancreatitis. The remaining subjects were controls without pan
creatic pathology. Bile salt-dependent lipase was determined by a sand
wich enzyme-linked immunosorbent assay using polyclonal antibodies. Am
ylase and CA 19-9 antigen were also determined. In sera from control p
atients, the mean level of bile salt-dependent lipase was 1.5 mug/L. T
his level is quite similar to that of patients with benign liver disea
ses (1.1 mug/L) and with chronic pancreatitis (1.4 mug/L), but it was
raised to 3.5 mug/L in patients with acute pancreatitis and decreased
to 0.5 mug/L in subjects with pancreatic adenocarcinoma. Thirty percen
t of control subjects and 73% of cancer patients had a bile salt-depen
dent lipase serum level below the cutoff value of 0.5 mug/L. In acute
pancreatitis, 11 of 16 subjects had levels above 1.5 mug/L. Amylase le
vel largely increased in acute pancreatitis but was normal in all othe
r groups. Concerning CA 19-9 antigen, 65% of control patients and >80%
of patients with non-malignant pancreatic or liver diseases had norma
l levels. In sera from cancer patients, 80% presented with high levels
. Accordingly, 36 of 38 patients with pancreatic cancer had either low
serum levels of bile salt-dependent lipase (<0.5 mug/L) or high value
s of CA 19-9 antigen (>37 U/ml; sensitivity 95%). In control patients
2 of 30 had low levels of enzyme or elevated levels of CA 19-9 (specif
icity 94%). Therefore, assay of the serum level of bile salt-dependent
lipase, alone or more usefully in conjunction with CA 19-9 antigen, h
elps to diagnose pancreatic carcinoma and to discriminate malignant di
seases from either chronic or acute pancreatitis.