Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

Summary

The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.

Timeline

Start

2010-03

Primary completion

2013-05

Completion

2013-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Lidocaine vs Normal Saline; p = .45; Chi-squared; note: .05 was set as level of significance NCT00953199 ↗

Publications

• Background Cosen-Binker LI, Binker MG, Negri G, Tiscornia O. Acute pancreatitis possible initial triggering mechanism and prophylaxis. Pancreatology. 2003;3(6):445-56. doi: 10.1159/000074972. Epub 2003 Nov 19.
• Background Kiyonari Y, Nishina K, Mikawa K, Maekawa N, Obara H. Lidocaine attenuates acute lung injury induced by a combination of phospholipase A2 and trypsin. Crit Care Med. 2000 Feb;28(2):484-9. doi: 10.1097/00003246-200002000-00033.
• Background Makela A, Kuusi T, Schroder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest. 1997 Aug;57(5):401-7. doi: 10.3109/00365519709084587.
• Background Portiansky EL, Gonzalez PH. Protective effect of lidocaine in the experimental foot-and-mouth disease pancreatitis. Experientia. 1995 Nov 15;51(11):1060-2. doi: 10.1007/BF01946916.
• Background Schroder T, Kinnunen PK, Lempinen M. Xylocaine treatment in experimental pancreatitis in pigs. Scand J Gastroenterol. 1978;13(7):863-5. doi: 10.3109/00365527809182204.
• Background Schwartz JJ, Lew RJ, Ahmad NA, Shah JN, Ginsberg GG, Kochman ML, Brensinger CM, Long WB. The effect of lidocaine sprayed on the major duodenal papilla on the frequency of post-ERCP pancreatitis. Gastrointest Endosc. 2004 Feb;59(2):179-84. doi: 10.1016/s0016-5107(03)02540-9.

Drugs

Indications