Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

NCT03708458 | Unknown Phase 4

• 1 other identifier: PEP_2017
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-ERCP Pancreatitis

Keywords

endoscopic retrograde cholangiopancreatography (ERCP); post-ERCP pancreatitis (PEP); Nonsteroidal anti-inflammatory drugs (NSAID's); acetylcysteine (ACC)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control group

ACTIVE COMPARATOR

Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP

Drug: indomethacin suppository

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

Drug: indomethacin suppository; Drug: N-acetylcysteine (NAC)

Group B

ACTIVE COMPARATOR

Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP

Drug: indomethacin suppository

Interventions

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

Control group; Group A; Group B

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

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years and older
• diagnosis of choledocholithiasis
• indication for ERCP procedures
• willingness to participate in the study
• the ability to sign the informed consent

You may not qualify if:

• presence of acute pancreatitis or other inflammatory diseases at admission
• pregnancy
• contraindication for NSAID administration
• recent episode of upper digestive bleeding (less than one month)
• hypersensibility to antioxidants hypersensibility to antioxidants
• the necessity of a prophylactic pancreatic stent insertion
• patients' disapproval to take part in the study

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași

Iași, cod 700111, Romania

RECRUITING

Related Publications (8)

• 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.

  PMID: 25148137 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.

  PMID: 24099466 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.

  PMID: 26775631 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.

  PMID: 26290647 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.

  PMID: 26074713 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.

  PMID: 15990827 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.

  PMID: 22494121 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.

  PMID: 27133971 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• GHEORGHE BALAN, PhD, Professor

  "GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAŞI

  STUDY DIRECTOR

Central Study Contacts

LAURA PAVEL, PhD Student

CONTACT

+40751129600; laura_pavel_88@yahoo.com

GABRIELA STEFANESCU, PhD, Lecturer

CONTACT

+40744244266; gabriela.stefanescu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Student

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 17, 2018
• Study Start: April 1, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

RO (1)