Gastric CancerNCT04641455
Use of Mucolytic Solution Before Upper Endoscopy
A study testing Espumisan, N acetylcystein and Water in people with Gastric Cancer and Gastroscopy, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroscopy
- What is being tested?
- Espumisan, N acetylcystein and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years, signed informed consent, diagnostic gastroscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Digestive Diseases Center
Ostrava, 70300
Michal Stepan, M.D., +420595633207, stepan.michal@seznam.cz
About this study
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
Read the 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.
- Conditions
- Gastric Cancer, Gastroscopy
- Being tested
- Espumisan, N acetylcystein, Water
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Espumisan, N acetylcysteinDrug
Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
Espumisan, N acetylcysteinDrug
Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
WaterDrug
Administration of water before upper endoscopy
| Study group | Role | What they receive |
|---|---|---|
| A mucolytic solution | Experimental | 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 Receives: Drug: Espumisan, N acetylcystein |
| B mucolytic solution | Active comparator | 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 Receives: Drug: Espumisan, N acetylcystein |
| C Water | Placebo comparator | 100 ml of water 20-30 minutes prior to upper endoscopy Receives: Drug: Water |
| D No intervention | No intervention | Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 5 months
Secondary outcomes (1)
Visibility score" evaluated by two blinded endoscopists using 10 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).
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Štěpán, M.D., Vitkovice Hospital
- Investigators
- Michal Stepan, M.D., Principal investigator, Digestive Diseases Center, Vítkovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641455
- Sponsor's protocol ID
- DDC VN 10
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mucolytic Solution Before Upper Endoscopy
- ClinicalTrials.gov ID
- NCT04641455
- Acronym / sponsor ID
- DDC VN 10
- Conditions
- Gastric Cancer, Gastroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A mucolytic solution | Experimental | Drug: Espumisan, N acetylcysteinmucolytic 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 |
| B mucolytic solution | Active comparator | Drug: Espumisan, N acetylcysteinmucolytic 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 |
| C Water | Placebo comparator | Drug: Water100 ml of water 20-30 minutes prior to upper endoscopy |
| D No intervention | No intervention | –Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 years, signed informed consent, diagnostic gastroscopy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Espumisan, N acetylcysteinAdministration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg) | Drug | A mucolytic solution |
| Espumisan, N acetylcysteinAdministration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg) | Drug | B mucolytic solution |
| WaterAdministration of water before upper endoscopy | Drug | C Water |
Primary outcome
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).
1 secondary outcome
Visibility score" evaluated by two blinded endoscopists using 10 endoscopic images captured during endoscopy
Time frame: through study completion, an average of 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Stepan, M.D. principal investigator
Digestive Diseases Center, Vítkovice Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Espumisan, N acetylcystein and Water in people with Gastric Cancer and Gastroscopy, run by Vitkovice Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Stepan, M.D. (+420595633207, stepan.michal@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility score" evaluated by blinded performing endoscopist (time frame: through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.