Prospective randomized blinded comparison of a short-wire endoscopic retrograde cholangiopancreatography system with traditional long-wire devices.
BACKGROUND
Short-wire endoscopic retrograde cholangiopancreatography (ERCP) systems are perceived to carry advantage over traditional long-wire devices. To date, this potential advantage has not been well documented, and gastroenterologists are confronted in everyday practice with the dilemma of choosing a particular system without the benefit of having objective comparative data.


OBJECTIVE
The aim of this study was to compare the performance characteristics of the Fusion ERCP short-wire system with traditional long-wire devices.


METHODS
This is a prospective, blinded, randomized, controlled trial. Patients with a clinical indication for ERCP were randomized to undergo the procedure with the Fusion short-wire system or long-wire devices. All procedures were done by one experienced endoscopist who was blinded to the outcomes of the study. The person recording the outcomes was an independent observer not involved in the procedure and was blinded to the study hypothesis. The main outcome was device exchange time. Secondary outcomes included stent insertion time, total procedure time, fluoroscopy time, cannulation time, successful cannulation of the desired duct, and complications.


RESULTS
A total of 71 patients were enrolled. The short-wire system provided for significantly faster mean device exchange time (125 versus 177 s; P = 0.05) and stent insertion time (135 versus 254 s; P < 0.001) as compared with the long-wire system. A trend towards shorter total procedure time, fluoroscopy time, and cannulation time was noted with the short-wire system but did not reach statistical significance. Successful cannulation of the desired duct was achieved in all patients. Post-ERCP pancreatitis occurred in one patient in the short-wire and in two patients in the long-wire group.


CONCLUSIONS
This short-wire system provides for significantly shorter device exchange and stent insertion times compared with traditional long-wire devices.
Draganov
Peter V
PV
Department of Medicine, University of Florida, Gainesville, FL 32610, USA. dragapv@medicine.ufl.edu
Kowalczyk
Lukasz
L
Fazel
Ali
A
Moezardalan
Koorosh
K
Pan
Jen-Jung
JJ
Forsmark
Chris E
CE
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000175:diagnosis*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000295:instrumentation*; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D055815:Young Adult