Use of Mucolytic Solution Before Upper Endoscopy

Sponsor

Vitkovice Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04641455

Collaborator

(none)

120

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastroscopy	Drug: Espumisan, N acetylcystein Drug: Espumisan, N acetylcystein Drug: Water	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Use of Mucolytic Solution Before Upper Endoscopy

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

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)
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 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.

Outcome Measures

Primary Outcome Measures

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

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).

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Diseases Center	Ostrava		Czechia	70300

Sponsors and Collaborators

Vitkovice Hospital

Investigators

Principal Investigator: Michal Stepan, M.D., Digestive Diseases Center, Vítkovice Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michal Štěpán, M.D., Principal investigator, Vitkovice Hospital

ClinicalTrials.gov Identifier:

NCT04641455

Other Study ID Numbers:

DDC VN 10

First Posted:

Nov 23, 2020

Last Update Posted:

Nov 23, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Nov 23, 2020