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The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP |
|
| Group A | Active Comparator | Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP |
|
| Group B | Active Comparator | Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indomethacin suppository | Drug | the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who develop post ERCP pancreatitis | Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis | 24 hours post ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LAURA PAVEL, PhD Student | Contact | +40751129600 | laura_pavel_88@yahoo.com | |
| GABRIELA STEFANESCU, PhD, Lecturer | Contact | +40744244266 | gabriela.stefanescu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| GHEORGHE BALAN, PhD, Professor | "GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAÅžI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași | Recruiting | Iași | cod 700111 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25148137 | Background | Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22. | |
| 24099466 |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| N-acetylcysteine (NAC) | Drug | the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens |
|
| Background |
| Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16. |
| 26775631 | Background | Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9. |
| 26290647 | Background | Gooshe M, Abdolghaffari AH, Nikfar S, Mahdaviani P, Abdollahi M. Antioxidant therapy in acute, chronic and post-endoscopic retrograde cholangiopancreatography pancreatitis: An updated systematic review and meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9189-208. doi: 10.3748/wjg.v21.i30.9189. |
| 26074713 | Background | Fuentes-Orozco C, Davalos-Cobian C, Garcia-Correa J, Ambriz-Gonzalez G, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Chavez-Tostado M, Cuesta-Marquez LA, Alvarez-Villasenor AS, Cortes-Flores AO, Gonzalez-Ojeda A. Antioxidant drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: What does evidence suggest? World J Gastroenterol. 2015 Jun 7;21(21):6745-53. doi: 10.3748/wjg.v21.i21.6745. |
| 15990827 | Background | Katsinelos P, Kountouras J, Paroutoglou G, Beltsis A, Mimidis K, Zavos C. Intravenous N-acetylcysteine does not prevent post-ERCP pancreatitis. Gastrointest Endosc. 2005 Jul;62(1):105-11. doi: 10.1016/s0016-5107(05)01574-9. |
| 22494121 | Background | Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103. |
| 27133971 | Background | Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28. |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |