- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641455
Use of Mucolytic Solution Before Upper Endoscopy
November 17, 2020 updated by: Michal Štěpán, M.D., Vitkovice Hospital
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
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)
120
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
- Name: Michal Stepan, M.D.
- Phone Number: +420595633207
- Email: stepan.michal@seznam.cz
Study Locations
-
-
-
Ostrava, Czechia, 70300
- Recruiting
- Digestive Diseases Center
-
Contact:
- Michal Stepan, M.D.
- Phone Number: +420595633207
- Email: stepan.michal@seznam.cz
-
-
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
16 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, allergy to mucolytic solution components, pregnancy
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
|
Active Comparator: 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
|
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
|
Placebo Comparator: C Water
100 ml of water 20-30 minutes prior to upper endoscopy
|
Administration of water before upper endoscopy
|
No Intervention: D No intervention
Upper endoscopy without neither mucolytic solution nor water prior to 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 5 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 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy
Time Frame: through study completion, an average of 5 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 5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual fluid in the stomach evaluated by blinded performing endoscopist
Time Frame: through study completion, an average of 5 months
|
0-3 point scale
|
through study completion, an average of 5 months
|
Duration of endoscopy
Time Frame: through study completion, an average of 5 months
|
time between introduction and withdrawal of the endoscopy
|
through study completion, an average of 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michal Stepan, M.D., Digestive Diseases Center, Vìtkovice Hospital
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 (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
May 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Actual)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDC VN 10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Gastric Cancer
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
Clinical Trials on Espumisan, N acetylcystein
-
Tehran University of Medical SciencesUnknownAcute Myocardial InfarctionIran, Islamic Republic of
-
Assaf-Harofeh Medical CenterUnknownQuality of Life | ExerciseIsrael
-
Soroka University Medical CenterCompletedHypertension | Diabetes Mellitus Type 2
-
Assistance Publique - Hôpitaux de ParisTerminatedCannabis Dependence | Cannabis AbuseFrance
-
Psychiatric University Hospital, ZurichSwiss Federal Institute of Technology; Zurich Center for Integrative Human... and other collaboratorsCompletedCocaine AddictionSwitzerland
-
University of LeipzigCompletedMyocardial InfarctionGermany
-
Johnson & Johnson Consumer and Personal Products...CompletedFunctional DyspepsiaRussian Federation
-
Asan Medical CenterTerminatedBronchiolitis Obliterans | Graft vs Host DiseaseKorea, Republic of
-
Assiut UniversityNot yet recruitingThalassemia Major
-
Seoul National University HospitalCompleted