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Pharmacological Prophylaxis Versus Pancreatic Duct Stenting Plus Pharmacological Prophylaxis for Prevention of Post-Ercp Pancreatitis in High Risk Patients: A Randomized Trial Publisher Pubmed



Sotoudehmanesh R1, 2 ; Aliasgari A1, 2 ; Khatibian M1, 2 ; Mohamadnejad M1, 3 ; Merat S1, 2, 3 ; Sadeghi A1, 2 ; Keshtkar A4 ; Bagheri M1, 2 ; Delavari A1, 3 ; Amani M1, 3 ; Vahedi H1, 2 ; Nasserimoghaddam S1, 2, 3 ; Sima A1, 2 ; Eloubeidi MA5 Show All Authors
Authors
  1. Sotoudehmanesh R1, 2
  2. Aliasgari A1, 2
  3. Khatibian M1, 2
  4. Mohamadnejad M1, 3
  5. Merat S1, 2, 3
  6. Sadeghi A1, 2
  7. Keshtkar A4
  8. Bagheri M1, 2
  9. Delavari A1, 3
  10. Amani M1, 3
  11. Vahedi H1, 2
  12. Nasserimoghaddam S1, 2, 3
  13. Sima A1, 2
  14. Eloubeidi MA5
  15. Malekzadeh R1, 2, 3
Show Affiliations
Authors Affiliations
  1. 1. Liver and Pancreaticobiliary Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Shariati Hospital, Kargar Shomali Avenue, Tehran, Iran
  2. 2. Digestive Disease Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Digestive Oncology Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Health Science Educational Development, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Anniston Digestive Health, Anniston, AB, United States

Source: Endoscopy Published:2019


Abstract

Background, Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. Methods, In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. Results, During 21 months, a total of 414 patients (mean age 55.5 ± 17.0 years; 60.2 % female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3 %, 95 % confidence interval [CI] 11.1 % - 17.9 %: 26 patients [12.6 %, 95 %CI 8.6 % - 17.6 %] in group A and 33 [15.9 %, 95 %CI 11.4 % - 21.4 %] in group B). There was no significant difference between the two groups in PEP severity (P = 0.59), amylase levels after 2 hours (P = 0.31) or 24 hours (P = 0.08), and length of hospital stay (P = 0.07). Conclusions, The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients. © Georg Thieme Verlag KG Stuttgart New York.