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Rectal Indomethacin Or I.V. Gabexate Mesylate As Prophylaxis for AP ERCP European Review for Medical and Pharmacological Sciences 2017; 21: 5268-5274 Rectal indomethacin or intravenous gabexate mesylate as prophylaxis for acute pancreatitis post-endoscopic retrograde cholangiopancreatography V. GUGLIELMI, M. TUTINO, V. GUERRA, P. GIORGIO National Institute of Gastroenterology, “S. de Bellis” Research Hospital Castellana Grotte, Bari, Italy Abstract. – OBJECTIVE: We aimed to evaluate mechanisms of AP are obstruction of the com- the results in our case series of AP ERCP over mon bile duct by stones, and alcohol abuse. En- the last three years. The prophylaxis for acute doscopic retrograde cholangiopancreatography pancreatitis (AP) post-endoscopic retrograde (ERCP) is the most frequent iatrogenic cause. cholangiopancreatography (ERCP) consists of rectal indomethacin, but some studies are not Post-ERCP AP is the most common and fear concordant. some adverse event for this procedure. In the PATIENTS AND METHODS: We compared 241 United States this complication costs $150 mil- ERCP performed from January 2014 to February lion annually for American Healthcare2,3 and it 2015 with intravenous gabexate mesylate (Group is a common cause of endoscopy-related lawsu- A), with the 387 ERCP performed from March its against gastroenterologists in the world. It 2015 to December 2016 with rectal indometha- has a significant morbidity and rare mortality cin (Group B) as prophylaxis for AP post-ERCP. RESULTS: There were 8 (3.31%) AP post-ERCP rate. About 10% of post-ERCP AP is moderate in Group A vs. 4 (1.03%) in Group B. or severe. Post-ERCP severe AP is associated CONCLUSIONS: Rectal indomethacin shows a with a higher mortality than non-ERCP-indu- better statistically significant performance than ced pancreatitis, but without statistical eviden- intravenous gabexate mesylate in the prophylax- ce4. Post-ERCP AP has a prevalence of 5%, is of AP post-ERCP, besides being cheaper. which is 2% in patients at low risk. More than 35 drugs have been studied for the prophylaxis Key Words: of post-ERCP AP. Nowadays, indomethacin se- Post-ERCP acute pancreatitis, Indomethacin, Gabex- ems to be the best, but gabexate mesylate was ate mesylate. used for many years5,6. Non-steroidal anti-in- flammatory drugs (NSAIDs) are also known to have a protective action7-9. They are potent inhi- Introduction bitors of phospholipase A 2, cycloxygenase, and neutrophil-endothelial interactions. All these Acute pancreatitis (AP) is defined as a new inhibitors are believed to play an important role upper abdominal pain, with increased serum in the pathogenesis of AP, and NSAIDs seem amylase and/or lipase levels to at least three to provide an increased benefit over temporary times above the normal limit1. This acute in- pancreatic stents, the only proven prophylactic flammation frequently involves peripancreatic intervention for post-ERCP AP10-12. Besides, tissues and, sometimes, remote organ systems. NSAIDs are cheap and easily administered; According to the Atlanta classification1 forms, when given as a single dose, they have a low vary widely from mild, only affecting the pan- risk. Many works13,14 have reported the utili- creas, to severe disease with multi-organ fai- ty of rectal indomethacin as prophylaxis for lure and death. Mortality is higher in case of post-ERCP AP. We investigated the number of necrotizing pancreatitis (17%) than interstitial AP post-ERCP that occurred using intravenous pancreatitis (3%). In cases of infected necrosis gabexate mesylate as prophylaxis in our hospi- the mortality rate is 30%. The most frequent talized patients, from January 2014 to February 5268 Corresponding Author: V. Guglielmi, MD; e-mail: [email protected] Rectal indomethacin or i.V. gabexate mesylate as prophylaxis for AP ERCP 2015 vs. rectal indomethacin occurred from computations were made using Stata 10.0, Sta- March 2015, when the clinical evidence became tistical Software (StataCorp 2007, College Sta- overwhelming for the use of this NSAID, until tion, TX, USA). December 2016. Results Patients and Methods In Group A, there were 8 cases of AP Retrospectively, we analyzed 241 ERCP (3.31%) and in Group B 4 cases (1.03%) (Fi- performed from the 1st of January 2014 to 28th gure 1). Between the two groups no differen- February 2015 using gabexate mesylate (Isti- ces in terms of major risk factors were found: tuto Biochimico Giovanni Lorenzini, Aprilia, precut sphincterotomy except 1 (Group B) pa- LT, Italy), (1000 mg intravenously in 500 cc tient, clinical suspicion of sphincter of Oddi of saline solution during 24 h before ERCP) dysfunction, a history of post-ERCP AP, pan- as prophylaxis for AP (Group A), compared to creatic sphincterotomy, more than 8 cannula- 387 ERCP utilizing rectal indomethacin (a sup- tion attempts, pneumatic dilatation of an intact pository of 100 mg, Sigma-Tau Industrie Far- biliary sphincter except 1 (Group A) patient, maceutiche Riunite, Pomezia, Rome, Italy), (1 ampullectomy15, or minor risk factors: female h before ERCP) (Group B) from the 1st March sex, age less than 50 years, history of recurrent 2015 to 6th December 2016 when this work was pancreatitis, 3 or more injections of contrast started. In Group A there were 110 men, 131 agent into the pancreatic duct resulting in opa- women, mean age 74 years (range 23-98 years). cification of pancreatic acini, brushing of the In Group B, there were 196 men and 191 wo- pancreatic duct, minor operator experience. men, mean age 74 years (range 33-96 years). The duodenoscope used was always the same: The indications for ERCP, the complications Olympus TJFQ180V (Tokyo, Japan). None of and comorbidities of patients in Group A and our 12 patients with post-ERCP AP had active Group B, were shown in Tables I-II. pancreatitis before ERCP, creatinine level > 1.4 mg, and no one was already taking NSAIDs Statistical Analysis (other than cardio protective aspirin). In six The test for proportions of differences was patients in Group A (Table III), ERCP was per- used. Statistical significance of the differences formed for choledocic lithiasis, in one for cho- between the two proportions (3.32% vs. 3.1%) langiocarcinoma of the biliary tree (placement was p = 0.042. When testing the null hypothe- of prosthesis) and in one to change an occluded sis of no association, the level of probability of prosthesis (placed four months before for cho- error, two tailed, was 0.05. All the statistical langiocarcinoma). Cholangitis was observed in Figure 1. Percentual of cases of post-ERCP AP in Group A and Group B. 5269 V. Guglielmi, M. Tutino, V. Guerra, P. Giorgio Table I. Characteristics of patients of Group A Complications Exitus in Indication in number complications: Comorbidities % for ERCP % of cases number of cases Arterial hypertension 30 Choledocic lithiasis in previous 24 Post-ERCP acute cholecistectomy pancreatitis 8 0 Diabetes mellitus 13 Choledocic and cholelithiasis 21 Duodenal perforation 4 1 Ischemic cardiopathy 9 Cholangitis in choledocic lithiasis and previous cholecystectomy 16 Hematobilia 2 0 COPD 8 Biliary acute pancreatitis 10 Chronic liver disease 5 Cholangiocarcinoma 7 Atrial fibrillation 6 Choledocic stenosis for pancreas carcinoma 8 Pace-maker 4 Stenosis of previous sphyncterotomy 5 Obesity 3 Sepsis in choledocic lithiasis in previous cholecystectomy 3 Surrenal adenomas 2 Sepsis for occluded biliary prothesis in cholangiocarcinoma (the prothesis was changed) 3 Liver metastasis 2 Biliary leakage after cholecystectomy 1 Dyslipidemia 2 Primary sclerosing cholangitis 1 Aortic valve prothesis 2 Choledocic stenosis by liver hilar linfoadenopathy in colon carcinoma 1 Hyperthyroidism 2 Pleural effusion 2 Aortic insufficiency 2 Ascites 2 Pneumectomy for lung carncer 1 Sponteneous bacteric peritonitis 1 Carotid ateroma 1 Aortic aneurysm 1 Hiatal hernia 1 Primary sclerosing cholangitis 1 IPMT of pancreas 1 Crohn’s disease 1 Lung metastasis 1 Hypothyroidism 1 Chronic kidney failure 1 Alzheimer’ disease 1 Beta thalassemia 1 Depression 1 Parkinson’s disease 1 Inactive carrier of HBV 1 Kaposi’s sarcoma 0.2 three patients and one had sepsis. One patient fact, the cost of 10 vials of gabexate mesylate had hematobilia. No deaths occurred. In Group is 171.2 Euro and that of 500 ml of saline solu- B (Table IV), in all four patients the ERCP was tion is 1.5 euro, for a total cost of 172.7 euro for necessary for choledocic lithiasis. Two patients every patient in Group A. A suppository of 100 had cholangitis, one hematobilia and one he- mg of indomethacin costs 7.7 Euro, thus saving matobilia with duodenal perforation. This pa- 165 Euro for each patient in Group B. Thus, tient was treated not with surgical operation but for the 387 (Group B) patients the total saving with medical therapy. No deaths occurred. It is was 63.855 euro in 21 months (Figure 2). Also, important to underline the considerable sum we saved about ten days of hospital treatment saved with the use of rectal indomethacin. In to each patient protected from post-ERCP AP 5270 Rectal indomethacin or i.V. gabexate mesylate as prophylaxis for AP ERCP Table II. Characteristics of patients of Group B. Complications Exitus in Indication in number complications: Comorbidities % for ERCP % of cases number of cases Arterial hypertension 32 Choledocic lithiasis in previous cholecystectomy 25 Hematobilia 4 0 Diabetes mellitus 14 Choledocic and cholelithiasis 20 Post-ERCP pancreatitis 3 0 Ischemic cardiopathy 9 Cholangitis in choledocic lithiasis and previous cholecystectomy 17 Duodenal perforation+ Hematobilia+ acute pancreatitis
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