Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)

Summary

ERCP is a diagnostic and therapeutic procedure that is required in patients with suspected common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may occur as a complication of this procedure after about 5-10% of the ERCP procedures. This complication manifests as persisting pain 24 hours or more after ERCP, along with raised levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence of this complication is unpredictable. There have been a number of attempts to prevent this complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin, steroids, etc. However, these have not been successful. Recently, a study showed that application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors may also be effective. The investigators want to study whether transdermal patch of glyceryl trinitrate or administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent post-ERCP pancreatitis in our patients who undergo an ERCP.

Timeline

Start

2003-10

Primary completion

2005-09

Completion

2005-09

Publications

• Background Kaffes AJ, Bourke MJ, Ding S, Alrubaie A, Kwan V, Williams SJ. A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis. Gastrointest Endosc. 2006 Sep;64(3):351-7. doi: 10.1016/j.gie.2005.11.060. Epub 2006 May 19.
• Background Moreto M, Zaballa M, Casado I, Merino O, Rueda M, Ramirez K, Urcelay R, Baranda A. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7. doi: 10.1067/mge.2003.29.
• Background Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Lazzell-Pannell L, Rashdan A, Temkit M, Lehman GA. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol. 2006 Jan;101(1):139-47. doi: 10.1111/j.1572-0241.2006.00380.x.
• Background Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

Drugs

Indications