Botulinum Toxin Injection after Biliary Sphincterotomy: Reply to Dr. Cotton and Dr. Hawes

We would like to respond to the letter by Dr. Cotton and Dr. Hawes regarding our manuscript on Botox injection for the prevention of post-ERCP pancreatitis.

We agree that the rate of pancreatitis in our study was unacceptably high. We wish to point out that rates in this range were not uncommon in the published literature prior to the paper by Tarnasky et al. [1]. The study was initiated before that publication. It was during our study that the practice of pancreatic stenting became accepted as the standard of care for these high-risk patients, prompting the interim analysis discussed in our paper. We could not in good faith continue to put patients at increased risk of pancreatitis as the study design required, and the study was therefore terminated early.

We also currently practice the use of temporary pancreatic duct stenting in patients undergoing endoscopic therapy for sphincter of Oddi dysfunction, using small-gauge stents. We also have found a dramatic decrease in our overall pancreatitis rate in these patients. However, we feel that the volume of botulinum toxin injection used to create the pharmacological sphincterotomy is small, and the fear of local orifice occlusion is not sufficient to preclude future studies using this agent at the sphincter of Oddi.

Reference

• 1 Tarnasky P R, Palesch Y, Cunningham J. et al . Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.  Gastroenterology. 1998;  115 1518-1524