Background and Study Aims: The role of the needle knife at endoscopic
retrograde cholangiopancreatography (ERCP) remains controversial, with
conflicting views being held on the value and safety of this device.
The aim of the present study was to assess prospectively the value and
safety of suprapapilllary fistulosphincterotomy (FS) in the endoscopi
c management of biliary disease. Patients and Methods: Suprapapillary
fistulosphincterotomy was performed when biliary cannulation had faile
d after attempting to opacify the bile duct for 30 minutes, initially
with a standard diagnostic cannula and then by further attempts with a
tapered cannula. The second indication for suprapapillary fistulosphi
ncterotomy was inability to obtain satisfactory cannulation with the s
phincterotome in patients in whom cholangiograghy showed pathology req
uiring endoscopic sphincterotomy. Using this technique, apr opening ma
s created into the intraduodenal segment of the common bile duct at a
point on the vertical axis 3-5 mm proximal to the papillary orifice. T
he opening was then cannulated, and extended as required to facilitate
clearance of stones or stent insertion. Results: Of 531 consecutive p
atients, 83 (16%) underwent suprapapillary fistulosphincterotomy and b
iliary cannulation was achieved ire 74 of the 83 (89%). If suprapapill
ary fistulosphincterotomy had not been used, the diagnostic success ra
te would have fallen from 513 out of 531 (97%) to 451 out of 531 (85%)
(P = 0.0001); the clearance rate for duct stones would have fallen fr
om 150 out of 156 (96%) to 130 abet of 156 (83%) (P = 0.0003); and suc
cessful stent insertion mould have fallen from 52 out of 59 (88%) to 3
8 out of 59 (64%) (P = 0.0044). There were no fatalities following sup
rapapillary fistulosphincterotomy. Complications occurred in five of t
he 83 patients (6%) who underwent fistulosphincterotomy, compared with
five of the 448 patients (1%) who did not undergo the procedure (P =
0.01). Conclusions: Our results suggest that suprapapillary fistulosph
incterotomy is a valuable adjunct in the management of biliary disease
at ERCP, but, in view of the increased risk of complications, it shou
ld be reserved for patients in whom the index of suspicion fbr biliary
disease is high and further endoscopic treatment is likely.