Mucolytic Solution Before Upper Endoscopy

NCT ID: NCT02967094

Last Updated: 2016-11-29

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-31

Brief Summary

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Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of 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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Gastroscopy; Gastric Cancer

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 consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

B - no intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

C - water

100 ml of water given 30 minutes prior to upper endoscopy.

Group Type PLACEBO_COMPARATOR

Administration of water before upper endoscopy

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

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
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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Premysl Falt, M.D., Ph.D.

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Premysl Falt, M.D., Ph.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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Premysl Falt, M.D., Ph.D.

Role: CONTACT

Phone: +420595633

Email: [email protected]

Barbora Pipek, M.D.

Role: CONTACT

Phone: +420595633

Email: [email protected]

Facility Contacts

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Premysl Falt, M.D., Ph.D.

Role: primary

References

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Stepan M, Falt P, Pipek B, Fojtik P, Hanousek M, Hill M, Urban O. Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Mar;167(1):69-73. doi: 10.5507/bp.2021.038. Epub 2021 Jun 22.

Reference Type DERIVED
PMID: 34158672 (View on PubMed)

Other Identifiers

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DDC VN 09

Identifier Type: -

Identifier Source: org_study_id