Gastric Transit and Pharmacodynamics of a Two-Millimeter Enteric-Coated Pancreatin Microsphere Preparation in Patients with Chronic Pancreatitis MARCO J. BRUNO, MD, PhD, JUDOCUS J.J. BORM, MD, FRANS J. HOEK, PhD, BAREND DELZENNE, ALAN F. HOFMANN, MD, PhD, JEROEN J.M. DE GOEIJ, PhD, ERIC A. VAN ROYEN, MD, PhD, DIRK J. VAN LEEUWEN, MD, PhD, and GUIDO N.J. TYTGAT, MD, PhD It has been suggested that enteric-coated pancreatin microsphere (ECPM) preparations with sphere sizes larger than 1.7 mm pass through the stomach at a slower rate than a meal and therefore may be less ef®cacious in restoring pancreatic enzyme activity than preparations with smaller sphere sizes. The aim of this study was to investigate the gastric transit pro®le of a 2-mm ECPM preparation in relation to that of a solid meal and to simultane ously measure enzyme activitie s in eight patients with pancreatic exocrine insuf®ciency due to chronic pancreatitis. Gastric transit was assessed by double-isotope scintigraphy. A pancake was labe le d with 99m Tc. A 2-mm ECPM preparation was labe le d with 171 Er. Intraluminal pancreatic enzyme activitie s were assessed during a 6-hr period with the cholesteryl- [ 14 C]octanoate breath test (for carboxyl ester lipase activity) and the N-benzoyl- L-tyrosyl- p- aminobe nzoic acid/ p-aminosalicylic acid (NBT-PABA/PAS) test (for chymotrypsin activity). The ECPM preparation passed through the stomach more rapidly (median 24 min) than the pancake (median 52 min, P , 0.05). During ECPM therapy, mean cumulative 14 CO 2 outputs rose signi®cantly from 30% to 70% ( P , 0.05), but remained below outcomes in healthy volunte ers. Mean cumulative plasma PABA concentrations rose signi®cantly from 46% to 87% ( P , 0.05) and were not signi®cantly different from outcomes in healthy volunteers. In chronic pancreatitis, a 2-mm ECPM preparation does not pass through the stomach more slowly than a solid meal, but in fact faster. Digestion of ester lipids and proteins showed an improvement to subnormal and normal levels, respectively. KEY WORDS: chronic pancreatitis; exocrine pancreatic insuf®ciency; enzyme replacement therapy; pancreatin; enteric-coated microsphere therapy; erbiumoxide; gastric emptying. In the treatment of pancreatic exocrine insuf®ciency, enteric-coated pancreatin microsphere (ECPM) preparations are used with increasing frequency. These preparations offer partial protection against Manuscript received March 13, 1996; accepted December 27, 1996. From the Division of Gastroenterology and Hepatology, Depart- ment of Nuclear Medicine, and Department of Clinical Chemistry, Academic Medical Center, Amsterdam, The Netherlands; Division of Gastroenterology, University of California, San Diego, Califor- nia; Interfaculty Reactor Institute, Delft University of Technology, Delft, The Netherlands; and Division of Gastroenterology and Hepatology, University of Alabama, Birmingham, Alabama. This work was ®nancially supported by Knoll B.V., The Nether- lands. Part of this work was presented at the Annual meeting of the American Gastroenterological Association 1995, San Diego, Cali- fornia. Digestive Diseases and Sciences, Vol. 43, No. 1 (January 1998), pp. 203±213 203 Digestive Diseases and Sciences, Vol. 43, No. 1 (January 1998) 0163-2116/98/0100-0203$15.00/0 Ñ 1998 Plenum Publishing Corporation