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Use of Mucolytic Solution Before Upper Endoscopy

NCT ID: NCT04641455

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Gastric Cancer Gastroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Espumisan, N acetylcystein

Intervention Type DRUG

Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)

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

Group Type ACTIVE_COMPARATOR

Espumisan, N acetylcystein

Intervention Type DRUG

Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)

C Water

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DRUG

Administration of water before upper endoscopy

D No intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Espumisan, N acetylcystein

Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)

Intervention Type DRUG

Espumisan, N acetylcystein

Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)

Intervention Type DRUG

Water

Administration of water before upper endoscopy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitkovice Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michal Štěpán, M.D.

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Stepan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Digestive Diseases Center, Vítkovice Hospital

Locations

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Digestive Diseases Center

Ostrava, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Michal Stepan, M.D.

Role: CONTACT

Phone: +420595633207

Email: [email protected]

Facility Contacts

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Michal Stepan, M.D.

Role: primary

Other Identifiers

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DDC VN 10

Identifier Type: -

Identifier Source: org_study_id