Acta clin Croat 2001; 40:9-13 Original Scientific Paper 9 A RANDOMIZED, DOUBLE-BLIND TRIAL OF THE EFFICACY OF OCTREOTIDE ACETATE ADMINISTRATION IN THE PREVENTION OF ABDOMINAL PAIN FOLLOWING THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY Marko Duvnjak, Vladimir Supanc, Velimir ©imiËeviÊ, Davor Hrabar, Branko Troskot, Lea SmirËiÊ- Duvnjak, Rajko OstojiÊ 2 and Senka Rado eviÊ 3 Department ot Internal Medicine, Division of Gastroenterology and Hepatology. Sestre milosrdnice University Hospital Zagreb, Croatia; 2 Department of Gastroenterology Zagreb, University Hostipal Center, Zagreb, Croatia; 3 Pliva Fharmaceutical Company, Medical Affairs, Zagreb, Croatia SUMMARY Abdominal pain is a complication of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST). The aim of this trial was to investigate the effects of octreotide acetate in the prevention of abdominal pain in patients undergoing therapeutic ERCP. A double-blind study was carried out in 209 subjects who were randomly allocated to two groups (A and B). Group A (104 patients) received 0.5 mg of octreotide acetate subcutaneously one hour prior to ERCP; and group B (105 patients) were given placebo. Patients were assessed 2 and 24 hours following endoscopy for the following parameters: presence and character of abdominal pain, re- quirements of analgetics. Thirty-nine (18%) patients complained of post-ERCP pain, i.e. ten in group A and 29 in group B, all of them treated with analgetics. Of the ten group A patients, symptoms of acute pancreatitis were identified in four (3.85%) patients versus ten (9.52%) patients in the control group B. The results obtained in the study seem to indicate that octreotide pretreatment significantly reduced the development of post-ERCP pain. Key words: Cholangiopancreatograopy, endoscopic, retrograde, adverse effects; Octreotide, therapeutic use; Pancreatitis, prevention and control Correspondence to: Marko Duvnjak, M.D. Ph. D., Dept of Internal Medicine Division of gastroenterology and Hepatology. Sestre Milo- srdnice University Hospital Vinogradska c. 29 HR-10000 Zagreb, Croatia Received July 11, 2000, acepted in revised form February 21, 2001. Introduction Complications related to endoscopic retrograde cho- langiopancreatography (ERCP) represent a serious medi- cal problem for both the patient and physician. Possible complications following this procedure include a rise in serum amylase and lipase, acute pancreatitis, and epigas- tric pain 1 . The incidence of pancreatitis as the most se- vere complication following ERCP has been variously assessed to lie between 2% and 20% 1 . However, the fre- quency of biochemical abnormalities (increased serum pancreatic enzyme values) without clinical manifestations of acute pancreatitis is much higher, i.e. as much as 75% of patients according to a review by Booth et al. 2 , while episodes of post-ERCP epigastric pain have not been fully investigated. The pathogenesis of post-ERCP pain is not known. Some cases might have previously been explained by forced filling of the pancreatic duct and use of ionic con- trast medium 3 . However, avoiding ‘acinarization’ in pan- creatogram and changing to nonionic contrast medium have not made post-ERCP pancreatitis disappear. Like- wise, the presence of abdominal pain, with or without se- rum pancreatic enzyme increment, remains another sce- nario that may be expected following ERCP 4 .