Use of Mucolytic Solution Before Upper Endoscopy

Vitkovice Hospital

Status

Unknown

Conditions

Gastric Cancer

Gastroscopy

Treatments

Drug: Water

Drug: Espumisan, N acetylcystein

Study type

Interventional

Funder types

Other

Identifiers

NCT04641455

DDC VN 10

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 4 patient groups, including a placebo group

A mucolytic solution

Experimental group

Description:

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

Treatment:

Drug: Espumisan, N acetylcystein

B mucolytic solution

Active Comparator group

Description:

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

Treatment:

Drug: Espumisan, N acetylcystein

C Water

Placebo Comparator group

Description:

100 ml of water 20-30 minutes prior to upper endoscopy

Treatment:

Drug: Water

D No intervention

No Intervention group

Description:

Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.