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DOI: 10.1055/a-2681-2659
Influence of a defoaming agent – simethicone – on endoscope cleaning and disinfection: Prospective real-world study
Authors
Gefördert durch: National Clinical Research Base of Traditional Chinese Medicine in Jiangsu Province JD2023SZ04
Gefördert durch: Traditional Chinese and Western Medicine Colorectal Polyps Treatment Center Project of Jiangsu Provincial Hospital of Chinese Medicine
- Abstract
- Introduction
- Methods
- Results
- ATP values of cleaning endoscopes exposed to simethicone for 1 year
- Discussion
- Conclusions
- References
Abstract
Background and study aims
Simethicone has been extensively utilized in endoscopy examinations and therapies; however, consensus regarding its impact on endoscopy cleaning is still lacking. The aim of this study was to assess impact of simethicone use during endoscopic examination on efficacy of endoscope cleaning.
Methods
This was a prospective real-world study that involved use of varying concentrations of simethicone in the endoscope biopsy channel and auxiliary water channel.
Results
All simethicone residual amounts and adenosine triphosphate (ATP) values were analyzed every month for 1 year. Use of 1% and 2% concentrations of simethicone generally resulted in variations in residual simethicone levels between the two channels. There was no significant alteration in ATP values in any concentration between the two channels. However, there was a significant difference in ATP values between the two channels at the concentration of 1% simethicone. After 1 year of usage, suspected adherent was observed in the 2% simethicone group, whereas no crystals were detected adhering to the biopsy channel walls in the 1% group or the control group. Sensitivity analysis suggested that the study results did not differ between the gastroscopy and colonoscopy subgroups.
Conclusions
Simethicone may remain in the biopsy and water infusion channels, regardless of whether it is used or not. It is recommended to utilize a simethicone concentration of 1% or less when administering it through the biopsy or auxiliary water channels of the endoscope.
Introduction
Digestive endoscopy (e.g. gastroscopy, colonoscopy, and duodenoscopy) is a widely employed diagnostic procedure that enables early detection of cancer and contributes to reducing both its incidence and mortality rates [1]. Use of simethicone in endoscopy examinations effectively reduces gas bubbles in the gastrointestinal tract, thereby improving visual clarity and increasing the detection rate for adenomas and other lesions. This ultimately enhances overall quality of digestive endoscopy [2] [3] [4]. There are two ways to use simethicone: oral examination and intra-examination flushing. More than half of endoscopists have used simethicone directly to clean the mucous membrane of the stomach and intestines during endoscopy examination [5].
Utilization of simethicone during endoscopic examinations presents challenges and controversies in terms of endoscope cleaning and disinfection. Previous studies have indicated that utilization of simethicone as a defoamer beyond its designated concentration application may result in unsuccessful post-processing, prompting cautionary advice from endoscope manufacturers and experts [6]. However, based on a comprehensive review of the available evidence and extensive clinical expertise, the Endoscopic Retreatment Guideline (ICEG) from the American, Canadian, and Australian Gastroenterological Societies has concluded that there have been no publicly reported adverse events associated with use of simethicone during oral endoscopic examination. Therefore, they support its continued utilization during endoscopic procedures [7] [8]. There is still no consensus on this issue.
The present study was a prospective 1-year real-world study of the impact of simethicone use through both the biopsy and the auxiliary water channel on endoscope cleaning and disinfection. A total of 30 endoscopes were used in this study. Initially, we examined effects of a single application of simethicone at varying concentrations on both the water infusion and biopsy channels of endoscopes, with the aim of determining the appropriate concentration for use in real-world studies. Then, we dynamically observed residual simethicone in all endoscopic auxiliary water channels and biopsy channels by monthly testing for 1 year when doctors used simethicone from the biopsy channels and the water delivery channels. We also used an EyeMax endoscope (9F, Micro-tech Co., Ltd, China) to visualize biopsy holes in real time.
Methods
Study methodology
This was a real-world study. Initially, a preliminary test was performed to determine the most appropriate concentration of simethicone for real-world study by testing various concentrations containing 0%, 0.5%, 1%, 2%, and 3%. Subsequently, the optimal concentration of simethicone was utilized in a 1-year real-world study. The included endoscopes were used by physicians for gastrointestinal endoscopy or endoscopic treatment during the examination. These endoscopes use a constant concentration or no simethicone. At the end of each month, the concentration of simethicone, adenosine triphosphate (ATP) values, and images of biopsy channels were assessed ([Fig. 1]).
Endoscopy and its cleaning procedures
The Olympus endoscopes (11 colonoscopes and 19 gastroscopes) utilized in this study were equipped with an auxiliary water channel. The exclusive ID of gastroscopes were 2901424, 2403837, 2926822, 2926831, 2035987, 2926829, 2202513, 2926825, 2935609, 2926835, 2735030, 2735029, 2935610, 2002084, 2027916, 2935614, 2935619, 2001823, 2926827. The exclusive ID of colonoscopes were 2511287, 2944013, 2944012, 2742641, 2753817, 2943994, 2400664, 2742639, 2511286, 2742637, and 2753808. All endoscopes underwent manual cleaning procedures as illustrated in [Fig. 2] [9]. Detailed procedures are included in Supplementary Material 1.
Methods of preparing different concentrations of simethicone
The simethicone emulsion (Berlin Chemical Company, Germany) with a concentration of 40 mg/30 mL was utilized as treatment in this study. It was prepared to obtain concentrations of 0.5%, 1%, 2%, and 3%. A control group with a sterilized saline concentration of 0% simethicone was also included.
Methods for using simethicone
During the maintenance phase of the study, a single concentration of simethicone was utilized for water injection via the endoscope or biopsy port. With the water injection method via the biopsy channel, a 50-mL syringe was used to draw different concentrations of simethicone and inject it through the biopsy channel. With the water injection method via the auxiliary water channel, pre-mixed simethicone was used at varying concentrations with sterile saline. An auxiliary water pump device (Olympus, Japan) was connected to the system for the mixture injection through the ancillary auxiliary water channel. Endoscopy operators administered the simethicone-sterile saline solution, whereas researchers were responsible for sampling and testing. Throughout the study, endoscopies were performed for diagnostic examinations or surgical interventions.
Obtaining flushing solution of biopsy and auxiliary water channel
After the endoscope had been used, it was cleaned and disinfected according to the above steps. After it was completely dry, the injection pump was used to fill both the biopsy and auxiliary water channels with 200 mL of sterilized saline solution, and all of the solution was collected from the outlet hole of the endoscope. A total of 2 mL was used for the ATP fluorescence test and the rest was used for detection of simethicone residue.
Mass spectrometry method for detecting residual of simethicone
The concentration of the silicon element was determined to assess the residual amount of simethicone. Determination of silicon content was performed using a NexIon 350X ICP-MS instrument (PerkinElmer, United States). Monoelemental silicon standard solution (1000 μg/mL, National Center for Analysis and Testing of Nonferrous Metals and Electronic Materials, China) was appropriately diluted with 1% nitric acid to prepare a series of silicon element standard solutions: 0.05 μg/mL, 0.1 μg/mL, 0.2 μg/mL, 0.4 μg/mL, and 0.8 μg/mL. An internal standard solution containing 20 ng of scandium per mL was prepared by diluting a multi-element standard solution (10 μg/mL, National Center for Analysis and Testing of Nonferrous Metals and Electronic Materials, China) with 1% nitric acid (Suzhou Jingrui Chemical Co., Ltd., China). The series of standard solutions along with the internal standard solution were measured online using a peristaltic pump at appropriate proportions to obtain response values for the silicon element and the scandium element as vertical and horizontal coordinates, respectively, in order to construct a calibration curve. The test sample solution was also measured following the same procedure, allowing calculation of residual silicon content through the internal standard calibration curve method.
ATP testing for endoscope cleaning
A handheld ATP fluorescence detector (3M Clean-Trace LM1, Minnesota Mining & Manufacturing Company, United States), along with the corresponding consumables, was used, with meticulously attention to the instructions was provided in the user manual for conducting the test. ATP testing is a method for detecting organic residue, capable of reflecting presence of endoscope biofilms, cell debris, and other residue, which is helpful for assessing cleanliness of endoscopes and it partially reflects the impact of simethicone on microorganisms. This study utilized the ATP testing reaction to examine the impact of simethicone on endoscope cleaning.
Endoscopic images of biopsy channels
An EyeMAX endoscopy (9F, Micro-tech Co. Ltd, China) was used for imaging and storage of biopsy channels.
Statistical methods
Numerical values are expressed as mean ± SD. Paired t-tests are employed for comparing paired samples between two groups, whereas ANOVA tests or Fisher's exact probability tests are used for comparing multiple groups. P < 0.05 indicates statistical significance. PowerPoint (Microsoft, United States) was used for the creation of [Fig. 1] and [Fig. 2]. Graphpad Prisim 8 (Graphpad Software, United States) was used for data analysis, creation of [Fig. 3], [Fig. 4], and [Fig. 5] and combination of [Fig. 3], [Fig. 4], [Fig. 5], and [Fig. 6].
Results
Effect of single-use simethicone on residual simethicone and cleaning
Before starting the study, we selected 30 endoscopes (19 gastroscopies, 11 colonscopies) equipped with water delivery functionality from our center and randomly categorized them into five groups. Residual silicon content was analyzed. Our findings revealed no significant disparity in residual silicon content between the biopsy channel and the auxiliary water channel across five groups, thus establishing a fundamental basis for our subsequent investigations ([Fig. 3] a and [Fig. 3] b). Furthermore, there were no notable variations in ATP levels observed between the biopsy channel and the auxiliary water channel within these five groups ([Fig. 3] c and [Fig. 3] d).
Simethicone solutions were prepared at concentrations of 0.5%, 1%, 2%, and 3%, respectively, whereas a control group was set up using sterilized saline solution. Following a single flush of 200 mL, the channels underwent routine cleaning and disinfection before detection of residual simethicone content. In the biopsy channels, it was observed that an increase in simethicone solution concentration led to an increase in residual simethicone content, with a statistically significant difference observed when the concentration exceeded 1% ([Fig. 3] e). Similarly, in the auxiliary water channels, an increase in simethicone solution concentration resulted in higher residual simethicone content, with a statistically significant difference found when the concentration exceeded 2% ([Fig. 3] f). Residual simethicone was detected across five different concentrations. No significant difference in ATP values compared with the control group was found in the biopsy channels ([Fig. 3] g). In addition, no effect of simethicone concentration on microbial ATP value was observed in the auxiliary water channels ([Fig. 3] h). Comparison between residual sodium pentosan content in both biopsy and drainage channels revealed equal concentrations.
In general, the residual amount of simethicone in the biopsy channel and the auxiliary water channel was compared at the same concentration, revealing no significant difference. However, a discrepancy in residual simethicone content between the biopsy channel and the water delivery channel was observed only at a 1% concentration, with no notable differences found at other concentrations. Notably, there were no discernible variations in ATP values ([Fig. 3] i and [Fig. 3] j). Hence, a prospective real-world study will be conducted employing simethicone of 1% and 2% concentrations to ensure the study aligns with the rigorous standards of academic research.
Residual simethicone in endoscopes exposed to simethicone for > 1 year
The 30 endoscopes equipped with an auxiliary water channel were randomly selected and divided into three simethicone groups: 0%, 1%, and 2%, respectively. During the year of study maintenance, only one concentration of simethicone was used for water infusion or biopsy channel filling for this group. Residual simethicone was initially assessed, revealing no discernible differences among the three groups ([Fig. 4] a and [Fig. 4] b).
The residual simethicone test was conducted on each group at the end of every month. It was observed that in the biopsy channel, presence of residual simethicone in endoscopes using a 1.0% concentration was significantly higher by 11 months compared with those that had never been exposed to simethicone ([Fig. 4] c). However, there were no significant differences in residual simethicone between endoscopes using a 1.0% concentration and those without any prior exposure to simethicone in the auxiliary water channel. On the other hand, endoscopes utilizing a 2.0% concentration exhibited a statistically significant increase at 12 months in residual simethicone when compared with the control group ([Fig. 4] d).
The analysis encompassed examination of residual simethicone detected within a 1-year period in both biopsy and auxiliary water channels. In the water infusion channel, there was a significant increase in residual simethicone for both 1% and 2% concentrations compared with the control group ([Fig. 4] e). Within the biopsy channel, elevation in residual simethicone was observed with the 2% concentration, whereas no significant difference was found with the 1% concentration ([Fig. 4] f).
Statistical analysis of the biopsy channel and auxiliary water channel revealed a significant difference in average residual concentration of simethicone between the two channels, ranging from 1% to 2% ([Fig. 4] g). The raw data are in Supplementary Table 1 and Supplementary Table 2.
ATP values of cleaning endoscopes exposed to simethicone for 1 year
For the study, 30 endoscopes equipped with an auxiliary water channel were randomly selected and randomly divided into three groups of 10 each. Subsequently, ATP values were measured, and no significant differences were observed among the three groups ([Fig. 5] a and [Fig. 5] b). ATP testing was conducted monthly on each endoscope group, and administration of simethicone did not exert any influence on ATP values in either the biopsy channel or the auxiliary water channel ([Fig. 5] c and [Fig. 5] d). Analysis of all ATP values detected over a year revealed no significant alterations in ATP value in either of the two working channels ([Fig. 5] e and [Fig. 5] f).
When comparing the biopsy channel and the auxiliary water channel, no significant difference in ATP value was observed between the two channels overall. However, a disparity in ATP value between the two channels at a concentration of 1% was identified ([Fig. 5] g). The raw data are shown in Supplementary Table 3 and Supplementary Table 4.
Endoscopic examination of the biopsy channel inner wall following 1-year regular simethicone usage
Before conducting real-world studies, we visually examined the inner walls of 30 endoscopic biopsy channels. No visible crystals were observed adhering to the complete dry inner walls of the biopsy channels ([Fig. 6] a). After 1 year of usage, we observed dry adherent crystals in the 2% simethicone group, whereas no crystals were found adhering to the inner walls in either the 1% simethicone group or the control group ([Fig. 6] b).
Sensitivity analysis
Considering more frequent use of simethicone in colonoscopy, which typically involves a longer procedure duration compared with gastroscopy, it is plausible that this factor may influence residual presence of simethicone. Sensitivity analyses conducted for gastroscopy and colonoscopy subgroups did not reveal any disparities in terms of simethicone residue or microbial profiles between these two procedures, thereby indicating robustness and stability of our findings ([Table 1]).
Discussion
As early as 2016, Ofstead et al. [10] observed that residual drops in the endoscope channel resembled simethicone solution. Even after endoscopy reprocessing, the liquid containing simethicone remains on the inner wall of the biopsy channel. Simethicone is an inert, hydrophobic substance that may reduce reprocessing efficiency of endoscopy reprocessing. Simethicone usually contains sugar and thickeners, which may support microbial growth and biofilm development. Before further research on its safety, it is advised to minimize use of simethicone. Barakat et al. [11] demonstrated that despite undergoing high-level disinfection and drying procedures, residual fluid was still present in 42% to 95% of endoscope working channels. Utilization of medium/high concentration simethicone resulted in increased retention of droplets and higher ATP bioluminescence values within endoscope working channels compared with those treated with water or low-concentration simethicone. Therefore, they recommended considering use of a low concentration of simethicone and employing two cycles of automatic endoscope reprocessing machines for effective reprocessing. Several studies have demonstrated the efficacy of manual cleaning in effectively eliminating simethicone residue. Following a specific manual cleaning protocol during manual cleaning and/or high-level disinfection, no detectable droplets of simethicone were observed in the duodenoscope [9]. The effectiveness of addressing simethicone residue can potentially be enhanced through utilization of low concentration and manual decontamination methods.
Utilization of simethicone as an adjunct for endoscopic diagnosis and treatment is widely embraced by clinicians, with a majority of endoscopists (53%) reporting its application during colonoscopy procedures [5]. Most commonly, simethicone is administered through the biopsy or auxiliary water channel via a water pump. Moreover, studies have indicated that administering high doses of simethicone does not enhance visualization during capsule endoscopy [12]. Consequently, use of low-concentration simethicone in gastrointestinal endoscopy also aligns with clinical requirements.
In this study, we observed that utilization of simethicone during endoscopic examination and therapy resulted in residual simethicone, which was detected in both the biopsy and auxiliary water channels when using concentrations of 1% and 2% simethicone. Notably, no significant residual was found at a concentration of 1% simethicone in the auxiliary water channel; however, residual was present at a concentration of 2% simethicone. Considering these findings, if simethicone usage is necessary, careful consideration should be given to whether it should be administered through the biopsy or auxiliary water channels. Interestingly, at a concentration of 2% simethicone, the residual amount in the biopsy channel was lower compared with that in the auxiliary water channel. Conversely, at a concentration of 1%, there was less residual observed in the auxiliary water channel than in the biopsy channel. This discrepancy may potentially be attributed to variations in tube diameter and fluid viscosity. Therefore, administering simethicone with a concentration of 1% through the auxiliary water channel might represent a more favorable option. Utilization of simethicone during the examination does not compromise microbial detection; however, a concentration of simethicone exceeding 2% does elevate ATP levels, necessitating careful consideration. Following 1 year of simethicone administration, no observable damage was detected in the biopsy channel; nevertheless, suspicious simethicone crystals were observed adhering to the wall exclusively at a concentration of 2% simethicone. These crystals did not induce any visible physical harm to the inner channel wall; nonetheless, a long-term investigation may still be warranted for comprehensive evaluation. This study revealed absence of crystals when employing a 1% simethicone concentration, which could potentially represent data proximal to the cut-off value. Utilization of simethicone may lead to presence of residues in the biopsy and auxiliary water channels, even when following the current cleaning and disinfection protocols; moreover, a higher concentration results in an increased amount of residue. Utilization of simethicone does not exert impact on the cleaning present in the endoscope, indicating that our endoscope possesses inherent biosecurity irrespective of administration or omission of simethicone. The simethicone will not cause visible damage to the inner wall of the endoscope biopsy channel when properly hand-washed over 1 year of use.
This study also has several limitations. First, the ATP test was validated to assess whether adequate manual cleaning had been achieved and is not intended for use after high-level disinfection to detect viable microorganisms. ATP testing is a method primarily used to detect residual organic matter, such as biofilms and cell debris, and therefore, reflects the effectiveness of cleaning processes while only partially indicating the impact of simethicone on microbial presence. Second, this study was conducted at a single center and included data from only 1 year. To further validate the reliability of the findings, multicenter studies involving larger sample sizes are recommended.
Conclusions
In conclusion, it is recommended that a simethicone concentration of 1% or lower should be administered through the water supply or biopsy channel during endoscopic examinations and therapeutic procedures. This study provides valuable insights into the clinical application of simethicone, particularly with regard to endoscopic cleaning.
Contributorsʼ Statement
All authors contributed to data analysis, drafting, or revising of the article; agree on the journal to which the article is being submitted; provided final approval of the version to be published; and agree to be accountable for all aspects of the work.
Conflict of Interest
The authors declare that they have no conflict of interest.
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Two novel protocols for cleaning residual simethicone and fluid in patient-ready duodenoscopes.
J Gastroenterol Hepatol 2021; 36: 1843-1850
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Ofstead CL,
Wetzler HP,
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et al.
Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.
Am J Infect Control 2016; 44: 1237-1240
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Barakat MT,
Huang RJ,
Banerjee S.
Simethicone is retained in endoscopes despite reprocessing: impact of its use on working
channel fluid retention and adenosine triphosphate bioluminescence values (with video).
Gastrointest Endosc 2019; 89: 115-123
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Sey M,
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during capsule endoscopy. PloS One 2021; 16: e0249490
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Correspondence
Publikationsverlauf
Eingereicht: 24. November 2024
Angenommen nach Revision: 05. August 2025
Accepted Manuscript online:
11. August 2025
Artikel online veröffentlicht:
01. September 2025
© 2025. 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
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Juanjuan Huang, Tingsheng Ling, Junlin Zhang, Lianzhen Wei, Lei Chen, Huiwen Cao, Lei Wang, Yitong Liu, Dongkun Wen, Danrui Ren, Yang Li. Influence of a defoaming agent – simethicone – on endoscope cleaning and disinfection: Prospective real-world study. Endosc Int Open 2025; 13: a26812659.
DOI: 10.1055/a-2681-2659
-
References
- 1
Bretthauer M,
Løberg M,
Wieszczy P.
et al.
Effect of colonoscopy screening on risks of colorectal cancer and related death J.
N Engl J Med 2022; 387: 1547-1556
Reference Ris Wihthout Link
- 2
Sun X,
Xu Y,
Zhang X.
et al.
Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy:
a randomized clinical trial. Trials 2021; 22: 555
Reference Ris Wihthout Link
- 3
Ben Ner D,
Vainer I,
Toh ST.
et al.
Simethicone use in drug-induced sleep endoscopy improves visibility. Sleep Breath
2024; 28: 807-811
Reference Ris Wihthout Link
- 4
Yeh JH,
Hsu MH,
Tseng CM.
et al.
The benefit of adding oral simethicone in bowel preparation regimen for the detection
of colon adenoma: A systematic review and meta-analysis. J Gastroenterol Hepatol 2019;
34: 830-836
Reference Ris Wihthout Link
- 5
Nero J,
Moffatt D,
Park J.
et al.
Experience and perceptions of simethicone use during colonoscopy: A survey of North
American endoscopists. J Can Assoc Gastroenterol 2024; A172.
Reference Ris Wihthout Link
- 6
Ofstead CL,
Hopkins KM,
Eiland JE.
et al.
Widespread clinical use of simethicone, insoluble lubricants, and tissue glue during
endoscopy: A call to action for infection preventionists. Am J Infect Control 2019;
47: 666-670
Reference Ris Wihthout Link
- 7
Devereaux BM,
Taylor ACF,
Athan E.
et al.
Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological
Society of Australia. J Gastroenterol Hepatol 2019; 34: 2086-2089
Reference Ris Wihthout Link
- 8
Benmassaoud A,
Parent J.
Canadian Association of Gastroenterology Position Statement on the Impact of Simethicone
on Endoscope Reprocessing. J Can Assoc Gastroenterol 2018; 1: 40-42
Reference Ris Wihthout Link
- 9
Peng CL,
Liu TC,
Wang HP.
et al.
Two novel protocols for cleaning residual simethicone and fluid in patient-ready duodenoscopes.
J Gastroenterol Hepatol 2021; 36: 1843-1850
Reference Ris Wihthout Link
- 10
Ofstead CL,
Wetzler HP,
Johnson EA.
et al.
Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.
Am J Infect Control 2016; 44: 1237-1240
Reference Ris Wihthout Link
- 11
Barakat MT,
Huang RJ,
Banerjee S.
Simethicone is retained in endoscopes despite reprocessing: impact of its use on working
channel fluid retention and adenosine triphosphate bioluminescence values (with video).
Gastrointest Endosc 2019; 89: 115-123
Reference Ris Wihthout Link
- 12
Sey M,
Yan B,
McDonald C.
et al.
A randomized controlled trial of high volume simethicone to improve visualization
during capsule endoscopy. PloS One 2021; 16: e0249490
Reference Ris Wihthout Link