Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial
Study Details
Study Description
Brief Summary
The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.
To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.
The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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Study type: prospective, randomized, double-blinded, placebo-controlled trial: i. Prospective inclusion of patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Double-blinded - nurse instructed not to reveal treatment; patient and doctor unaware of treatment;
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Patient selection: consecutive series of patients scheduled for upper gastrointestinal endoscopy; Exclusion criteria - sedation, previous total gastrectomy, known neoplasia or stenosis, allergies to simethicone or N-acetylcysteine, therapeutic or urgent procedures;
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Sample size: 270 (3 groups of 90 patients): to improve "excellent" preparations from 20% (value from our own database) to 40% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 3 groups was 82; allowing for a 10% dropout rate, the sample size is 90 (270 patients overall); Groups: Group A - 100mL of water (placebo); Group B - 100mL of water plus 100mg Simethicone; Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine;
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Data collection methods: form sheet filled by nurses (appendix 1) and endoscopist (appendix 2);
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Analysed variables: patients characteristics (age, gender), indication for endoscopy, time from administration to procedure, score of mucosal visualization, side effects of medication;
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Statistical analysis: chi-square test.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Group A - 100mL of water by mouth, 15 to 30 minutes before endoscopy |
Other: Placebo
100mL of water
|
| Active Comparator: Simethicone Group B - 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy |
Drug: Simethicone
100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy
Other Names:
|
| Active Comparator: Simethicone plus N-acetylcysteine Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy |
Drug: Acetylcysteine
100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Score of mucosal visualization [1 day (During endoscopy)]
Evaluation of the visibility of gastric mucosa during upper endoscopy using a scale (excelent, adequadate or inadequate) for esophagus, stomach and duodenum
Other Outcome Measures
- Drug side effects [1 day (During endoscopy)]
Evaluation of the drug side effects during upper endoscopy (report of any allergic reaction)
Eligibility Criteria
Criteria
Inclusion Criteria:
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consecutive series of patients scheduled for upper gastrointestinal endoscopy
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signed informed consent
Exclusion Criteria:
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sedation
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previous total gastrectomy
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known neoplasia or stenosis
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therapeutic or urgent procedures
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allergies to simethicone or N-acetylcysteine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Portuguese Oncology Institute - Coimbra | Coimbra | Portugal | 3001-651 |
Sponsors and Collaborators
- Portuguese Oncology Institute, Coimbra
Investigators
- Principal Investigator: Luís Elvas, MD, Gastroenterology Department, Portuguese Oncology Institute - Coimbra
Study Documents (Full-Text)
None provided.More Information
Publications
- Ahsan M, Babaei L, Gholamrezaei A, Emami MH. Simethicone for the Preparation before Esophagogastroduodenoscopy. Diagn Ther Endosc. 2011;2011:484532. doi: 10.1155/2011/484532. Epub 2011 Aug 4.
- Asl SM, Sivandzadeh GR. Efficacy of premedication with activated Dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol. 2011 Oct 7;17(37):4213-7. doi: 10.3748/wjg.v17.i37.4213.
- 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 May;24(4):268-70.
- Bhandari P, Green S, Hamanaka H, Nakajima T, Matsuda T, Saito Y, Oda I, Gotoda T. Use of Gascon and Pronase either as a pre-endoscopic drink or as targeted endoscopic flushes to improve visibility during gastroscopy: a prospective, randomized, controlled, blinded trial. Scand J Gastroenterol. 2010 Mar;45(3):357-61. doi: 10.3109/00365520903483643.
- Chang CC, Chen SH, Lin CP, Hsieh CR, Lou HY, Suk FM, Pan S, Wu MS, Chen JN, Chen YF. Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol. 2007 Jan 21;13(3):444-7.
- Chang WK, Yeh MK, Hsu HC, Chen HW, Hu MK. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol. 2014 Apr;29(4):769-74. doi: 10.1111/jgh.12487.
- Chen MJ, Wang HY, Chang CW, Hu KC, Hung CY, Chen CJ, Shih SC. The add-on N-acetylcysteine is more effective than dimethicone alone to eliminate mucus during narrow-band imaging endoscopy: a double-blind, randomized controlled trial. Scand J Gastroenterol. 2013 Feb;48(2):241-5. doi: 10.3109/00365521.2012.749509. Epub 2012 Dec 27.
- Faigel DO, Eisen GM, Baron TH, Dominitz JA, Goldstein JL, Hirota WK, Jacobson BC, Johanson JF, Leighton JA, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; Standards of Practice Committee. American Society for Gastrointestinal Endoscopy. Preparation of patients for GI endoscopy. Gastrointest Endosc. 2003 Apr;57(4):446-50.
- Fujii T, Iishi H, Tatsuta M, Hirasawa R, Uedo N, Hifumi K, Omori M. Effectiveness of premedication with pronase for improving visibility during gastroendoscopy: a randomized controlled trial. Gastrointest Endosc. 1998 May;47(5):382-7.
- 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 Aug;93(8):892-7.
- Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4.
- Lee GJ, Park SJ, Kim SJ, Kim HH, Park MI, Moon W. Effectiveness of Premedication with Pronase for Visualization of the Mucosa during Endoscopy: A Randomized, Controlled Trial. Clin Endosc. 2012 Jun;45(2):161-4. doi: 10.5946/ce.2012.45.2.161. Epub 2012 Jun 30.
- Zala G, Flury R, Wüst J, Meyenberger C, Ammann R, Wirth HP. [Omeprazole/amoxicillin: improved eradication of Helicobacter pylori in smokers because of N-acetylcysteine]. Schweiz Med Wochenschr. 1994 Aug 9;124(31-32):1391-7. German.
- PortugueseOIC 001