Gastric Mucosal Lesion Clinical Trial
Official title:
Premedication With Simethicone and N-acetylcysteine in Improving Mucosal Visibility During Upper Endoscopy - a Prospective Double-blinded Randomized Controlled Trial
| Verified date | January 2016 |
| Source | Portuguese Oncology Institute, Coimbra |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Portugal: Data Protection Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | January 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - consecutive series of patients scheduled for upper gastrointestinal endoscopy - signed informed consent Exclusion Criteria: - sedation - previous total gastrectomy - known neoplasia or stenosis - therapeutic or urgent procedures - allergies to simethicone or N-acetylcysteine |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Portuguese Oncology Institute - Coimbra | Coimbra |
| Lead Sponsor | Collaborator |
|---|---|
| Portuguese Oncology Institute, Coimbra |
Portugal,
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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. — View Citation
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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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Drug side effects | Evaluation of the drug side effects during upper endoscopy (report of any allergic reaction) | 1 day (During endoscopy) | Yes |
| Primary | 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) | No |