Mucolytic Solution Before Upper Endoscopy

November 27, 2016 updated by: Premysl Falt, M.D., Ph.D., Vitkovice Hospital

The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial

Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic, 70384
        • Recruiting
        • Digestive Diseases Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)
No Intervention: B - no intervention
Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.
Placebo Comparator: C - water
100 ml of water given 30 minutes prior to upper endoscopy.
Drug: Administration of water before upper endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Visibility score" evaluated by blinded performing endoscopist
Time Frame: through study completion, an average of 3 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).
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.
Time Frame: through study completion, an average of 3 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).
through study completion, an average of 3 months
Residual fluid in the stomach evaluated by blinded performing endoscopist
Time Frame: through study completion, an average of 3 months
0-3 point scale
through study completion, an average of 3 months
Duration of endoscopy
Time Frame: through study completion, an average of 3 months
time between introduction and withdrawal of the endoscopy
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitkovice Hospital

Investigators

  • Principal Investigator: Premysl Falt, M.D., Ph.D., Digestive Diseases Center, Vìtkovice Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 27, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDC VN 09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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