Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study

Michal Stepan, Premysl Falt, Barbora Pipek, Petr Fojtik, Martin Hanousek, Martin Hill, Ondrej Urban, Michal Stepan, Premysl Falt, Barbora Pipek, Petr Fojtik, Martin Hanousek, Martin Hill, Ondrej Urban

Abstract

Aims: Sufficient visibility of the mucosa during upper endoscopy is crucial for successful diagnosis, especially for early neoplastic lesions. Data documenting the effect of administration of mucolytic solution prior to gastroscopy in order to improve mucosal visibility are limited in Europe. The aim of the study was to assess the score of mucosal visibility in the upper gastrointestinal tract after administration of the mucolytic solution defined by us.

Patients and methods: This is a monocentric, double-blind, randomized study involving 134 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with mucolytic solution (100 mL water + 400 mg N-acetylcysteine + 20 mg simethicone), without the solution , and with 100 mL pure water. During the examination, 11 photographs were taken in defined areas. The visibility score was given by the sum of the score 0-5 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid.

Results: The basic characteristics of the group (sex, age, indications for examination) were comparable between arms. The visibility score was similar in all arms - 17.4 ± 1.9 vs. 17.0 ± 2.0 vs. 17.6 ± 1.8 (P=0.32). The examination time and the amount of residual fluid in the stomach were comparable in all arms.

Conclusions: Administration of the mucolytic solution in our study did not increase the mucosal visibility score in the esophagus, stomach and duodenum.

Trial registration: ClinicalTrials.gov, NCT02967094.

Keywords: N-acetylcysteine; mucolytic solution; simethicon; upper endoscopy; visibility score.

Conflict of interest statement

The authors report no conflicts of interest in this work.

References

    1. Peery AF, Dellon ES, Lund J, Crockett SD, McGowan ChE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll ChF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology 2012;143(5):1179-87.
    1. Januszewicz W, Kaminski MF. Quality indicators in diagnostic upper gastrointestinal endoscopy. Therap Adv Gastroenterol 2020;13:1756284820916693. doi: 10.1177/1756284820916693
    1. Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2016;48:843-64.
    1. Monrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzales J, Espino A, Gonzales R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointesti Endosc 2018;87(4):986-93. doi: 10.1016/j.gie.2017.10.005
    1. Chang Ch, Chen S, Lin Ch, Hsieh Ch, Lou H, Suk F, Pan S, Wu M, Chen J, ChenY.Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: An endoscopist-blinded, prospective, randomized study. World J Gastroenterol 2007;13(3):444-47.
    1. Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline-Update 2019. Endoscopy 2019;51(8):775-94.
    1. Chang W, Yeh M, Hsu H, Chen H, Hu M. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol 2014;29(4):769-74.
    1. Keeratichananont S, Sobhonslidsuk A, Kitiyakara T, Achalanan N, Soonthornpun S. The role of liquid simethicone in enhancing endoscopic visibility prior to Esophagogastroduodenoscopy (EGD): A prospective, randomized, double-blinded, placebo-controlled trial: J Med Assoc Thai 2010;93(8): 892-7.
    1. Veeraraghavan K, Abel J, Shreyas V, Malini T, Vijayaraghavan D, Sangeetha A, Kurien G. Efficacy of simethicone and N-acetylcystein combination premedication prior to esophagogastroduodenoscopy to improve mucosal visibility-a prospective double blinded randomized placebo controlled trial. Endoscopy 2018;50(04):75.
    1. Elvas L, Areia M, Brito D, Alves S, Saraiva S, Cadime AT. Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial. Endoscopy 2017;49(2):139-45.
    1. Bertoni G, Gumina C, Conigliaro R, Ricci E, Staffetti J, Mortilla MG, Pacchione D. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy 1992;24(4):268-70.
    1. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston Bowel Preparation Scale: A valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009;69(3):620-25.
    1. Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol 2013;26(1):11-22.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj