Use of Mucolytic Solution Before Upper Endoscopy

Not Applicable

• Conditions: Gastroscopy; Gastric Cancer
• Interventions: Drug: Espumisan, N acetylcystein; Drug: Water

• Registration Number: NCT04641455
• Lead Sponsor: Vitkovice Hospital

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-23
• Last Update Posted: 2020-11-23
• Study Start: 2020-12-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A mucolytic solution	Espumisan, N acetylcystein	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	Espumisan, N acetylcystein	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	Water	100 ml of water 20-30 minutes prior to upper endoscopy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Digestive Diseases Center; 🇨🇿 Ostrava, Czechia