RSS-Feed abonnieren

DOI: 10.1055/a-2157-5034
Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial
Gefördert durch: Sint Antonius Research Fund NATRIAL REGISTRATION: Registration number (trial ID): NL8383, Trial registry: Netherlands National Trial Register (http://www.trialregister.nl), Type of Study: Prospective, randomized, multicenter study

Abstract
Background and study aims Simethicone is useful as premedication for upper endoscopy because of its antifoaming effects. We aimed to evaluate the effect of timing of simethicone administration on mucosal visibility.
Patients and methods In this multicenter, randomized, endoscopist-blinded study, patients scheduled for upper endoscopy were randomized to receive 40 mg simethicone at the following time points prior to the procedure: 20 to 30 minutes (early group), 0 to 10 minutes (late group) or 20 mg simethicone at both time points (split-dose group). Images were taken from nine predefined locations in the esophagus, stomach, and duodenum before endoscopic flushing. Each image was scored on mucosal visibility by three independent endoscopists on a 4-point scale (lower scores indicating better visibility), with adequate mucosal visibility defined as a score ≤ 2. Primary outcome was the percentage of patients with adequate total mucosal visibility (TMV), reached if all median subscores for each location were ≤ 2.
Results A total of 386 patients were included (early group: 132; late group: 128; split-dose group: 126). Percentages of adequate TMV were 55%, 42%, and 61% in the early, late, and split-dose group, respectively (P < 0.01). Adequate TMV was significantly higher in the split-dose group compared to the late group (P < 0.01), but not compared to the early group (P = 0.29). Differences between groups were largest in the stomach, where percentages of adequate mucosal visibility were higher in the early (68% vs 53%, P = 0.03) and split-dose group (69% vs 53%, P = 0.02) compared to the late group.
Conclusions Mucosal visibility can be optimized with early simethicone administration, either as a single administration or in a split-dose regimen.
Keywords
Precancerous conditions & cancerous lesions (displasia and cancer) stomach - Barrett's and adenocarcinoma - Preparation, quality and logistical aspects - Quality management - Diagnosis and imaging (inc chromoendoscopy, NBI, iSCAN, FICE, CLE)Publikationsverlauf
Eingereicht: 12. Mai 2023
Angenommen nach Revision: 25. Juli 2023
Artikel online veröffentlicht:
17. Oktober 2023
© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Beck M, Bringeland EA, Qvigstad G. et al. Gastric cancers missed at upper endoscopy in central Norway 2007 to 2016 – a population-based study. Cancers (Basel) 2021; 13: 5628
- 2 Januszewicz W, Witczak K, Wieszczy P. et al. Prevalence and risk factors of upper gastrointestinal cancers missed during endoscopy: A nationwide registry-based study. Endoscopy 2022; 54: 653-660
- 3 Pimenta-Melo AR, Monteiro-Soares M, Libânio D. et al. Missing rate for gastric cancer during upper gastrointestinal endoscopy: A systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2016; 28: 1041-1049
- 4 Rodríguez de Santiago E, Hernanz N, Marcos-Prieto HM. et al. Rate of missed oesophageal cancer at routine endoscopy and survival outcomes: A multicentric cohort study. United European Gastroenterol J 2019; 7: 189-198
- 5 van Putten M, Johnston BT, Murray LJ. et al. ‘Missed’ oesophageal adenocarcinoma and high-grade dysplasia in Barrett’s oesophagus patients: A large population-based study. United European Gastroenterol J 2018; 6: 519-528
- 6 Yalamarthi S, Witherspoon P, McCole D. et al. Missed diagnoses in patients with upper gastrointestinal cancers. Endoscopy 2004; 36: 874-879
- 7 Manfredi G, Pedaci M, Iiritano E. et al. Impact of improved upper endoscopy quality on detection of gastric precancerous lesions. Eur J Gastroenterol Hepatol 2023; 35: 285-287
- 8 Early DS, Lightdale JR, Vargo JJ. et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2018; 87: 327-337
- 9 Bisschops R, Areia M, Coron E. et al. Performance measures for upper gastrointestinal endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2016; 48: 843-864
- 10 Gotoda T, Uedo N, Yoshinaga S. et al. Basic principles and practice of gastric cancer screening using high-definition white-light gastroscopy: Eyes can only see what the brain knows. Digestive Endoscopy 2016; 28: 2-15
- 11 Chiu PWY, Uedo N, Singh R. et al. An Asian consensus on standards of diagnostic upper endoscopy for neoplasia. Gut 2019; 68: 186-197
- 12 Chang WK, Yeh MK, Hsu HC. et al. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. Journal of Gastroenterology and Hepatology (Australia) 2014; 29: 769-774
- 13 Elvas L, Areia M, Brito D. et al. Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: A double-blind randomized trial. Endoscopy 2017; 49: 139-145
- 14 Song M, Kwek ABE, Law NM. et al. Efficacy of small-volume simethicone given at least 30 min before gastroscopy. World J Gastrointest Pharmacol Ther 2016; 7: 572-578
- 15 Krishnamurthy V, Joseph A, Venkataraman S. et al. Simethicone and N-acetyl cysteine combination as premedication before esophagogastroduodenoscopy: Double-blind randomized controlled trial. Endosc Int Open 2022; 10: E585-E592
- 16 Keeratichananont S, Sobhonslidsuk A, Kitiyakara T. et al. The role of liquid simethicone in enhancing endoscopic visibility prior to esophagogastroduodenoscopy ( EGD):. J Med Assoc Thai 2010; 93: 892-897
- 17 Ahsan M, Babaei L, Gholamrezaei A. et al. Simethicone for the preparation before esophagogastroduodenoscopy. Diagn Ther Endosc 2011; 2011: 484532
- 18 Asl SMKH, Sivandzadeh GR. Efficacy of premedication with activated Dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol 2011; 17: 4213-4217
- 19 Banerjee B, Parker J, Waits W. et al. Effectiveness of preprocedure simethicone drink in improving visibility during esophagogastroduodenoscopy: a double-blind, randomized study. J Clin Gastroenterol 1992; 15: 264-265
- 20 Basford P, Brown J, Gadeke L. et al. A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy – NICEVIS. Endosc Int Open 2016; 04: E1197-E1202
- 21 Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc 2021; 35: 303-308
- 22 Sajid MS, Rehman S, Chedgy F. et al. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone ± N-acetylcysteine. Transl Gastroenterol Hepatol 2018; 3: 1-8
- 23 Bertoni G, Gumina C, Conigliaro R. et al. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy 1992; 24: 268-270
- 24 Blanco C, Barreto-Guevara MI, Walteros-Gordillo YL. et al. Cohorts of premedication for endoscopy of the upper gastrointestinal tract with simethicone, n-acetylcysteine, hedera helix and visual scale validation. Rev Colomb Gastroenterol 2021; 36: 39-50
- 25 Manfredi G, Bertè R, Iiritano E. et al. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open 2021; 9: E190-E194
- 26 Monrroy H, Vargas JI, Glasinovic E. et al. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc 2018; 87: 986-993
- 27 Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: 698-702
- 28 Vickerstaff V, Omar RZ, Ambler G. Methods to adjust for multiple comparisons in the analysis and sample size calculation of randomised controlled trials with multiple primary outcomes. BMC Med Res Methodol 2019; 19: 1-13
- 29 Harris PA, Taylor R, Thielke R. et al. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377-381
- 30 Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 1988; 75: 383-386
- 31 Hassan C, East J, Radaelli F. et al. Bowel preparation for colonoscopy: European society of gastrointestinal endoscopy (ESGE) guideline-update 2019. Endoscopy 2019; 51: 775-794
- 32 Saltzman JR, Cash BD, Pasha SF. et al. Bowel preparation before colonoscopy. Gastrointest Endosc 2015; 81: 781-794
- 33 Sun X, Xu Y, Zhang X. et al. Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial. Trials 2021; 22: 4-10
- 34 Woo JG, Kim TO, Kim HJ. et al. Determination of the optimal time for premedication with pronase, dimethylpolysiloxane, and sodium bicarbonate for upper gastrointestinal endoscopy. J Clin Gastroenterol 2013; 47: 389-392
- 35 Khan R, Gimpaya N, Vargas JI. et al. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy 2023; 55: 121-128