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Mucolytic Solution Before Upper Endoscopy

Primary Purpose

Gastroscopy; Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Czech Republic

Study Type

Interventional

Intervention

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

Administration of water before upper endoscopy

About this trial

This is an interventional diagnostic trial for Gastroscopy; 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

Sites / Locations

Digestive Diseases CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Placebo Comparator

Arm Label

A - mucolytic solution

B - no intervention

C - water

Arm Description

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.

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

100 ml of water given 30 minutes 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 three blinded endoscopists using 11 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).

Residual fluid in the stomach evaluated by blinded performing endoscopist

0-3 point scale

Duration of endoscopy

time between introduction and withdrawal of the endoscopy

Full Information

NCT ID

NCT02967094

First Posted

November 10, 2016

Last Updated

November 27, 2016

Sponsor

Vitkovice Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02967094

Brief Title

Mucolytic Solution Before Upper Endoscopy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vitkovice Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Gastroscopy; Gastric Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A - mucolytic solution

Arm Type

Experimental

Arm Description

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.

Arm Title

B - no intervention

Arm Type

No Intervention

Arm Description

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

Arm Title

C - water

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

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 3 months

Secondary Outcome Measure Information:

Title

"Visibility score" evaluated by three blinded endoscopists using 11 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 3 months

Title

Residual fluid in the stomach evaluated by blinded performing endoscopist

Description

0-3 point scale

Time Frame

through study completion, an average of 3 months

Title

Duration of endoscopy

Description

time between introduction and withdrawal of the endoscopy

Time Frame

through study completion, an average of 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+420595633

Ext

205

faltprem@centrum.cz

First Name & Middle Initial & Last Name or Official Title & Degree

Barbora Pipek, M.D.

Phone

+420595633

Ext

205

barbora.pipek@seznam.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Premysl Falt, M.D., Ph.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

70384

Country

Czech Republic

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

+420602689561

faltprem@centrum.cz

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34158672

Citation

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.

Results Reference

derived

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