Comparison of Fatty Meal, Drotaverine and Hyoscine for Duodenal Anti-motility and Cannulation During ERCP- A Randomised Controlled Trial

Abstract

Introduction: Endoscopic Retrograde Cholangiopancreatography (ERCP) is a technically demanding procedure that requires considerable amount of training to be performed safely. Successful cannulation of the ducts depends on the expertise of the endoscopist. Conventionally, cannulation is facilitated with the help of smooth muscle relaxants like Hyoscine-N-butyl bromide or Drotaverine which impair duodenal contractions and facilitate sphincter of oddi relaxation. Aim: To compare the effect of Fatty meal versus Drotaverine hydrochloride versus Hyoscine-N-butyl bromide on duodenal contraction rate, ease of identification of the papillary orifice, time for cannulation, and adverse effects of agents used on haemodynamic parameters. Materials and Methods: The study was conducted at Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai,Tamil Nadu, India, where 60 patients admitted for ERCP with normal appearing ampulla, were taken-up for the study. Patients were subjected randomly into the three groups viz., Hyoscine group, Drotaverine group and Fatty meal group. In Fatty meal group, 200 mL of semi skimmed milk (1.7% fat) was given orally one hour prior to the procedure to allow for gastric emptying. A 20 mg of intravenous Hyoscine-N-butyl bromide and 40 mg of intravenous Drotaverine hydrochloride were administered 15 minutes before procedure in Hyoscine and Drotaverine group, respectively. Statistical analysis was done by Chi-square test and Analysis of Variance (ANOVA) test and using Statistical Package for the Social Sciences (SPSS) 16.0 version software. A p-value <0.05 was considered significant. Results: The difference in duodenal motility, cannulation time and success of the procedure did not show a statistically significant p-value between the three groups. The identification of ampulla was easy with the fatty meal group. The statistical analysis for intraprocedural change in pulse rate and Blood Pressure (BP) variation showed a significant p-value for Hyoscine group compared to the other two groups. The change in pulse rate for Hyoscine vs. Drotaverine vs. Fatty meal group during the procedure was 51.5±12.8 vs. 24.2±8.4 vs. 24.4±8.8 per minute, respectively. The variation in BP during the procedure was 18.3/15.7±7.7/9.0 mmHg vs. 9.0/8.7±5.7/5.6 mmHg vs. 10.4/8.6±4.6/3.3 mmHg for Hyoscine vs. Drotaverine vs. Fatty meal group respectively. Conclusion: Fatty meal is not inferior to the conventionally used Hyoscine-N-butyl bromide or Drotaverine for its anti-motility effect on the duodenum during ERCP. The cannulation time is no different within the groups. Fatty meal, the action of which is physiological may be used as a suitable alternative to antispasmodic pharmacological agents which have potential adverse effects.