Mucolytic Solution Before Upper Endoscopy

Study Overview
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Brief Summary
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Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.

Detailed Description
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Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.

Official Title
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The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial

Conditions
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Gastroscopy; Gastric Cancer

Intervention / Treatment
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* Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)
* Drug: Administration of water before upper endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years signed informed consent diagnostic gastroscopy Exclusion Criteria: age < 18 years interventional gastroscopy known disease of the upper GI tract and/or history of surgery of GI tract gastroscopy indicated of bleeding, dysphagia or ileus liver cirrhosis general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - mucolytic solution<br>Mucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy. | Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)<br> <br> |
| No Intervention: B - no intervention<br>Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. | |
| Placebo Comparator: C - water<br>100 ml of water given 30 minutes prior to upper endoscopy. | Drug: Administration of water before upper endoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility score evaluated by blinded performing endoscopist | Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5). | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility score evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy. | Visibility score (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5). | through study completion, an average of 3 months | 
| Residual fluid in the stomach evaluated by blinded performing endoscopist | 0-3 point scale | through study completion, an average of 3 months | 
| Duration of endoscopy | time between introduction and withdrawal of the endoscopy | through study completion, an average of 3 months |