Prospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Feb 6, 2019; 7(3): 300-310
Published online Feb 6, 2019. doi: 10.12998/wjcc.v7.i3.300
Split-dose or hybrid nonsteroidal anti-inflammatory drugs and N-acetylcysteine therapy for prevention of post-retrograde cholangiopancreatography pancreatitis
Laura Pavel, Gheorghe Gh Bălan, Alexandra Nicorescu, Georgiana Emmanuela Gîlcă-Blanariu, Cătălin Sfarti, Ștefan Chiriac, Smaranda Diaconescu, Vasile Liviu Drug, Gheorghe Bălan, Gabriela Ștefănescu
Laura Pavel, Gheorghe Gh Bălan, Georgiana Emmanuela Gîlcă-Blanariu, Cătălin Sfarti, Ștefan Chiriac, Vasile Liviu Drug, Gheorghe Bălan, Gabriela Ștefănescu, Gastroenterology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
Alexandra Nicorescu, Endocrinology, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
Smaranda Diaconescu, Department of Mother and Child Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, Iași 700115, România
Author contributions: Pavel L, Bălan GG, Gîlcă-Blanariu GE, Bălan G and Ștefănescu G, participated in the protocol design, identification and inclusion of candidates, collection of clinical information, and patient follow-up; Bălan GG, Sfarti C, Drug VL, Chiriac Ș band Bălan G performed the endoscopic interventions; Pavel L, Diaconescu S, Nicorescu A and Ștefănescu G participated in the protocol design and statistical analysis; all authors were involved in critical review of the results and approved the final manuscript.
Institutional review board statement: The Institutional Review Board of “Gr. T. Popa” University of Medicine and Pharmacy - Iași provided approval for this study (IRB No. 27/03/2017).
Clinical trial registration statement: This study is registered at ClinicalTrials.gov, registration number NCT03708458.
Informed consent statement: Consent was obtained from all the patients that were included in the study.
Conflict-of-interest statement: The authors declare that they have no competing interests.
CONSORT 2010 statement: The CONSORT 2010 Statement was uploaded.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Smaranda Diaconescu, MD, PhD, Associate Professor, Department of Mother and Child Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, 16 Universității str, Iași 700115, România. turti23@yahoo.com
Telephone: +40-74492216 Fax: +40-232222453
Received: October 30, 2018
Peer-review started: October 31, 2018
First decision: November 15, 2018
Revised: December 18, 2018
Accepted: December 21, 2018
Article in press: December 24, 2018
Published online: February 6, 2019
Processing time: 92 Days and 11.9 Hours
ARTICLE HIGHLIGHTS
Research background

Endoscopic retrograde cholangiopancreatography (ERCP) represents a complex endoscopic technique, which is almost exclusively used nowdays for therapeutic intent. Although ERCP should be a safe procedure for the vast majority of patients, postprocedural complications may arise, among which post-ERCP pancreatitis (PEP) is the most frequently reported.

Research motivation

PEP still remains an important concern with respect to its prophylaxis and management, especially considering the paucity of prospective trials in ERCP regarding this complication.

Research objectives

This study aimed to evaluate the efficacy of three prophylactic approaches for preventing PEP, using pharmacologic agents with different mechanisms of action (indomethacin in various doses with or without an extra dose of N-acetylcysteine (NAC) for prevention of acute pancreatitis in patients with choledocholithiasis and indication for undergoing ERCP.

Research methods

The study design was that of a prospective, single-blind randomized trial for comparing and dynamically evaluating the efficacy of the three pharmacological combination therapies.

Research results

Both split-dose administration of indomethacin (50 mg pre- and post-ERCP) and combined administration of 600 mg NAC before the procedure with per-rectum administration of 100 mg indomethacin post-ERCP showed similar efficacy in preventing PEP, as compared to the standard, guideline-reccommended regimen (per-rectum administration of 100 mg indomethacin post-ERCP).

Research conclusions

The results of this prospective randomized control trial support the potential use of various pharmacologic pathogenic regimens for the prophylaxis of PEP, showing similar efficacy and safety profiles. However, considering other potential prophylactic approaches, using either intravenous nonsteroidal anti-inflammatory drugs or aggressive intravenous hydration, double-blind prospective randomized controlled trials would offer stronger evidence for establishing prophylactic strategies in PEP.

Research perspectives

Considering these findings, further research in the field (eventually, through multicentric studies, enrolling high number of patients and modulating the antioxidant dose) could lead to developing more a efficient prophylactic pharmacological approach, with a satisfactory safety profile and tenable costs.