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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A mucolytic solution | Experimental | 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 |
|
| B mucolytic solution | Active Comparator | 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 |
|
| C Water | Placebo Comparator | 100 ml of water 20-30 minutes prior to upper endoscopy |
|
| D No intervention | No Intervention | Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Espumisan, N acetylcystein | Drug | Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Residual fluid in the stomach evaluated by blinded performing endoscopist | 0-3 point scale | through study completion, an average of 5 months |
| Duration of endoscopy | time between introduction and withdrawal of the endoscopy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Stepan, M.D. | Contact | +420595633207 | stepan.michal@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Michal Stepan, M.D. | Digestive Diseases Center, VÃtkovice Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Diseases Center | Recruiting | Ostrava | 70300 | Czechia |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C024632 | Espumisan |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Espumisan, N acetylcystein | Drug | Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg) |
|
| Water | Drug | Administration of water before upper endoscopy |
|
| through study completion, an average of 5 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |