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Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of 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 consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy. |
|
| B - no intervention | No Intervention | Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. | |
| C - water | Placebo Comparator | 100 ml of water given 30 minutes prior to upper endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) | Drug |
| ||
| Administration of water before upper endoscopy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Premysl Falt, M.D., Ph.D. | Contact | +420595633 | 205 | faltprem@centrum.cz |
| Barbora Pipek, M.D. | Contact | +420595633 | 205 | barbora.pipek@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Premysl Falt, M.D., Ph.D. | Digestive Diseases Center, VÃtkovice Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Diseases Center | Recruiting | Ostrava | 70384 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34158672 | Derived | Stepan M, Falt P, Pipek B, Fojtik P, Hanousek M, Hill M, Urban O. Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Mar;167(1):69-73. doi: 10.5507/bp.2021.038. Epub 2021 Jun 22. |
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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 |
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| Drug |
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |