Mucolytic Solution Before Upper Endoscopy

Not Applicable

• Conditions: Gastroscopy; Gastric Cancer
• Interventions: Drug: Administration of water before upper endoscopy; Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)

• Registration Number: NCT02967094
• Lead Sponsor: Vitkovice Hospital

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Last Update Submitted: 2016-11-27
• Last Update Posted: 2016-11-29
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C - water	Administration of water before upper endoscopy	100 ml of water given 30 minutes prior to upper endoscopy.
A - mucolytic solution	Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)	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.

Primary Outcome Measures

Name	Time	Method
"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 Outcome Measures

Name	Time	Method
Residual fluid in the stomach evaluated by blinded performing endoscopist	through study completion, an average of 3 months	0-3 point scale
"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).
Duration of endoscopy	through study completion, an average of 3 months	time between introduction and withdrawal of the endoscopy

Trial Locations

Locations (1)

Digestive Diseases Center; 🇨🇿 Ostrava, Czech Republic