Gastric Cancer, Gastroscopy
Conditions
Brief summary
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
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.
Interventions
DRUGEspumisan, N acetylcystein
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
DRUGWater
Administration of water before upper endoscopy
Sponsors
Vitkovice Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility score evaluated by blinded performing endoscopist | through study completion, an average of 5 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visibility score evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy | through study completion, an average of 5 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Residual fluid in the stomach evaluated by blinded performing endoscopist | through study completion, an average of 5 months | 0-3 point scale |
| Duration of endoscopy | through study completion, an average of 5 months | time between introduction and withdrawal of the endoscopy |
Countries
Czechia
Contacts
Primary ContactMichal Stepan, M.D.
Outcome results
None listed