Gastroscopy; Gastric Cancer
Conditions
Brief summary
Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of 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
DRUGAdministration of mucolytic solution before upper endoscopy (Espumisan, ACC long)
DRUGAdministration 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility score evaluated by blinded performing endoscopist | through study completion, an average of 3 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 three blinded endoscopists using 11 endoscopic images captured during endoscopy. | through study completion, an average of 3 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). |
| Residual fluid in the stomach evaluated by blinded performing endoscopist | through study completion, an average of 3 months | 0-3 point scale |
| Duration of endoscopy | through study completion, an average of 3 months | time between introduction and withdrawal of the endoscopy |
Countries
Czechia
Contacts
Primary ContactPremysl Falt, M.D., Ph.D.
Backup ContactBarbora Pipek, M.D.
Outcome results
None listed