• Soichi Itaba, Kazuhiko Nakamura, Akira Aso, Shoji Tokunaga, Hirotada Akiho, Eikichi Ihara, Yoichiro Iboshi, Tsutomu Iwasa, Kazuya Akahoshi, Tetsuhide Ito, and Ryoichi Takayanagi.
• Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University Hospital, Kyushu University, Fukuoka, Japan.
• Dig Endosc. 2013 Jul 1;25(4):421-7.

BackgroundDouble balloon endoscopy (DBE) allows the entire small intestine to be viewed using a combination of antegrade and retrograde approaches. Acute pancreatitis is a serious complication of antegrade DBE with no effective prophylactic treatment currently available. Ulinastatin has been shown to be effective for the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography. We therefore assessed the efficacy of ulinastatin for hyperenzymemia after antegrade DBE.Patients And MethodsForty-four patients were enrolled in this prospective, randomized, double-blind, placebo-controlled trial. Patients in the ulinastatin group received 150 000 U ulinastatin by i.v. drip infusion for 2 h from the start of the procedure. Serum concentrations of pancreatic amylase and lipase were measured before and 3 and 18 h after antegrade DBE.ResultsThe study was terminated after interim analysis. Of the 44 patients, 23 were randomized to ulinastatin and 21 to placebo.The groups were similar with regard to sex ratio, age, type of endoscope, insertion time, total procedure time, number of endoscope pull-back procedures, and baseline pancreaticamylase and lipase concentrations. Post-DBE hyperenzymemia was observed in 35.0% and 47.8% of patients in the placebo and ulinastatin groups, respectively. The higher frequency of hyperenzymemia in the ulinastatin group was unexpected, but the difference was not statistically significant. One patient in the placebo group (5.0%) and none in the ulinastatin group experienced acute pancreatitis, but the difference was not statistically significant.ConclusionThe results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.© 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

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