Mucolytic Solution Before Upper Endoscopy

Vitkovice Hospital

Status: Unknown

Conditions: Gastroscopy; Gastric Cancer

Treatments: Drug: Administration of water before upper endoscopy; Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)

Study type: Interventional

Funder types: Other

Identifiers

NCT02967094

DDC VN 09

Details and patient eligibility

About

Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of 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: 150 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

A - mucolytic solution

Experimental group

Description:

Mucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.

Treatment:

Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)

B - no intervention

No Intervention group

Description:

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

C - water

Placebo Comparator group

Description:

100 ml of water given 30 minutes prior to upper endoscopy.

Treatment:

Drug: Administration of water before upper endoscopy