Use of Mucolytic Solution Before Upper Endoscopy

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

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Gastroscopy
• Intervention / Treatment: Drug: Espumisan, N acetylcystein; Drug: Espumisan, N acetylcystein; Drug: Water

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia, 70300
    • Recruiting
    • Digestive Diseases Center
    • Contact: Michal Stepan, M.D.; Phone Number: +420595633207; Email: stepan.michal@seznam.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A mucolytic solution; 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	Drug: Espumisan, N acetylcystein; Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg); Drug: Espumisan, N acetylcystein; Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
Active Comparator: B mucolytic solution; 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	Drug: Espumisan, N acetylcystein; Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg); Drug: Espumisan, N acetylcystein; Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
Placebo Comparator: C Water; 100 ml of water 20-30 minutes prior to upper endoscopy	Drug: Water; Administration of water before upper endoscopy
No Intervention: D No intervention; Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vitkovice Hospital
• Investigators: Principal Investigator: Michal Stepan, M.D., Digestive Diseases Center, Vìtkovice Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: DDC VN 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No