A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy.

Results from studies evaluating needle-knife papillotomy are conflicting. The aim of this prospective trial was to assess the safety and efficacy of needle-knife papillotomy and compare the results with those of standard endoscopic sphincterotomy. During a period of 6 years, ERCP was performed 1680 times. Four hundred fifty-six patients had biliary obstruction and were candidates for endoscopic sphincterotomy. Cholangiography was successful in 414 subjects (91%). These individuals underwent endoscopic sphincterotomy, which was successful in 395; overall success rate for endoscopic sphincterotomy was 87% (395 of 456). Forty complications occurred (9.7%), but only 21 (5.1%) were serious. No procedure-related mortality occurred. Fifty-two of 456 patients (11%) were managed by needle-knife papillotomy. In 42 of these subjects, cholangiograms had failed or were incomplete, and endoscopic sphincterotomy was not attempted; in 10 individuals endoscopic sphincterotomy had failed. Needle-knife papillotomy was successful in 47 of 52 patients (90%). Three complications occurred (5.7%), only 2 of which (3.8%) were serious. Morbidity rates for needle-knife papillotomy and endoscopic sphincterotomy were not significantly different. No procedure-related mortality occurred. Needle-knife papillotomy increased the overall success rate for endoscopic management with sphincterotomy from 87% (success rate for endoscopic sphincterotomy alone) to 97% (success rate for endoscopic sphincterotomy and needle-knife papillotomy).(ABSTRACT TRUNCATED AT 250 WORDS)