search
Back to results

Use of Mucolytic Solution Before Upper Endoscopy

Primary Purpose

Gastric Cancer, Gastroscopy

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Espumisan, N acetylcystein
Espumisan, N acetylcystein
Water
Sponsored by
Vitkovice Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Digestive Diseases CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

No Intervention

Arm Label

A mucolytic solution

B mucolytic solution

C Water

D No intervention

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
November 17, 2020
Last Updated
November 17, 2020
Sponsor
Vitkovice Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04641455
Brief Title
Use of Mucolytic Solution Before Upper Endoscopy
Official Title
Use of Mucolytic Solution Before Upper Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A mucolytic solution
Arm Type
Experimental
Arm 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
Arm Title
B mucolytic solution
Arm Type
Active Comparator
Arm 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
Arm Title
C Water
Arm Type
Placebo Comparator
Arm Description
100 ml of water 20-30 minutes prior to upper endoscopy
Arm Title
D No intervention
Arm Type
No Intervention
Arm Description
Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.
Intervention Type
Drug
Intervention Name(s)
Espumisan, N acetylcystein
Intervention Description
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
Intervention Type
Drug
Intervention Name(s)
Espumisan, N acetylcystein
Intervention Description
Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
Intervention Type
Drug
Intervention Name(s)
Water
Intervention Description
Administration of water before upper endoscopy
Primary Outcome Measure Information:
Title
Visibility score" evaluated by blinded performing endoscopist
Description
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).
Time Frame
through study completion, an average of 5 months
Secondary Outcome Measure Information:
Title
Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy
Description
"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).
Time Frame
through study completion, an average of 5 months
Other Pre-specified Outcome Measures:
Title
Residual fluid in the stomach evaluated by blinded performing endoscopist
Description
0-3 point scale
Time Frame
through study completion, an average of 5 months
Title
Duration of endoscopy
Description
time between introduction and withdrawal of the endoscopy
Time Frame
through study completion, an average of 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Stepan, M.D.
Phone
+420595633207
Email
stepan.michal@seznam.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Stepan, M.D.
Organizational Affiliation
Digestive Diseases Center, Vítkovice Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Diseases Center
City
Ostrava
ZIP/Postal Code
70300
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Stepan, M.D.
Phone
+420595633207
Email
stepan.michal@seznam.cz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Mucolytic Solution Before Upper Endoscopy

We'll reach out to this number within 24 hrs