Use of Mucolytic Solution Before Upper Endoscopy

Gastric Cancer Clinical Trial

Official title:

Use of Mucolytic Solution Before Upper Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641455
• Other study ID #: DDC VN 10
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: Vitkovice Hospital
• Contact: Michal Stepan, M.D.
• Phone: +420595633207
• Email: stepan.michal[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroscopy
• Stomach Neoplasms

Intervention

Drug:
• Espumisan, N acetylcystein
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
• Espumisan, N acetylcystein
Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
• Water
Administration of water before upper endoscopy

Locations

Country	Name	City	State
Czechia	Digestive Diseases Center	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual fluid in the stomach evaluated by blinded performing endoscopist	0-3 point scale	through study completion, an average of 5 months
Other	Duration of endoscopy	time between introduction and withdrawal of the endoscopy	through study completion, an average of 5 months
Primary	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	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