Use of Mucolytic Solution Before Upper Endoscopy

Study Overview
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Brief Summary
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The study was designed to evaluate the effectiveness of the maximum dose of mucolytic solution used before upper endoscopy on the visibility of the 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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Use of Mucolytic Solution Before Upper Endoscopy

Conditions
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Gastric Cancer, Gastroscopy

Intervention / Treatment
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* Drug: Espumisan, N acetylcystein
* Drug: Espumisan, N acetylcystein
* Drug: Water


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, allergy to mucolytic solution components, pregnancy

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 - 100 ml of water + 600 mg of N-acetylcysteine (3 tablets of 200 mg ACC long), 320 mg of simethicone (8 ml of Espumisan sir. 40 mg / ml)administered 20-30 minutes prior to upper endoscopy | Drug: Espumisan, N acetylcystein<br>* Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)<br>|
| Active Comparator: B mucolytic solution<br>mucolytic solution-100 ml water + 400 mg N-acetylcysteine (2 tablets 200 mg ACC long), 20 mg simethicone (0.5 ml Espumisan sir. 40 mg / ml) administered 20-30 minutes prior to upper endoscopy | Drug: Espumisan, N acetylcystein<br>* Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)<br>|
| Placebo Comparator: C Water<br>100 ml of water 20-30 minutes prior to upper endoscopy | Drug: Water<br>* Administration of water before upper endoscopy<br>|
| No Intervention: D No intervention<br>Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. | |

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 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility score evaluated by two blinded endoscopists using 10 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 5 months |