Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

NCT02357303 | Completed Phase 4

• 1 other identifier: PortugueseOIC 001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Mucosal Lesion

Keywords

Randomized controlled trial; Endoscopy; Gastric mucosa; Simethicone; Acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Score of mucosal visualization

  Evaluation of the visibility of gastric mucosa during upper endoscopy using a scale (excelent, adequadate or inadequate) for esophagus, stomach and duodenum

  1 day (During endoscopy)

Other Outcomes (1)

• Drug side effects

  1 day (During endoscopy)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Group A - 100mL of water by mouth, 15 to 30 minutes before endoscopy

Other: Placebo

Simethicone

ACTIVE COMPARATOR

Group B - 100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy

Drug: Simethicone

Simethicone plus N-acetylcysteine

ACTIVE COMPARATOR

Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy

Drug: Acetylcysteine

Interventions

Simethicone DRUG

100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy

Also known as: Aero-OM

Simethicone

Acetylcysteine DRUG

100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy

Also known as: Fluimucil

Simethicone plus N-acetylcysteine

Placebo OTHER

100mL of water

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive series of patients scheduled for upper gastrointestinal endoscopy
• signed informed consent

You may not qualify if:

• sedation
• previous total gastrectomy
• known neoplasia or stenosis
• therapeutic or urgent procedures
• allergies to simethicone or N-acetylcysteine

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead

Study Sites (1)

Portuguese Oncology Institute - Coimbra

Coimbra, Coimbra District, 3001-651, Portugal

Location

Related Publications (14)

• 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. doi: 10.1016/s0016-5107(03)80006-8. No abstract available.

  PMID: 12665751 BACKGROUND

• 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.

  PMID: 22072853 BACKGROUND

• 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.

  PMID: 23268593 BACKGROUND

• 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.

  PMID: 20148732 BACKGROUND

• 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.

  PMID: 21826120 BACKGROUND

• 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. doi: 10.1055/s-2007-1010479.

  PMID: 1612040 BACKGROUND

• 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.

  PMID: 20718163 BACKGROUND

• 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. doi: 10.1055/s-2002-33220.

  PMID: 12170403 BACKGROUND

• 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.

  PMID: 22866258 BACKGROUND

• 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. doi: 10.1016/s0016-5107(98)70223-8.

  PMID: 9609431 BACKGROUND

• Zala G, Flury R, Wust 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.

  PMID: 8091167 BACKGROUND

• 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. doi: 10.3748/wjg.v13.i3.444.

  PMID: 17230616 BACKGROUND

• 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.

  PMID: 24325147 BACKGROUND

• 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 Feb;49(2):139-145. doi: 10.1055/s-0042-119034. Epub 2016 Nov 16.

  PMID: 27852098 DERIVED

MeSH Terms

Interventions

Simethicone; Acetylcysteine

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Luís Elvas, MD

  Gastroenterology Department, Portuguese Oncology Institute - Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 6, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

PT (1)