Gastroscopy; Gastric CancerNCT02967094
Mucolytic Solution Before Upper Endoscopy
A study testing Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) and Administration of water before upper endoscopy in people with Gastroscopy; Gastric Cancer, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroscopy; Gastric Cancer
- What is being tested?
- Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) and Administration of water before upper endoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2016to May 2017
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Digestive Diseases Center
Ostrava, 70384
Premysl Falt, M.D., Ph.D., +420602689561, faltprem@centrum.cz
About this study
Official title: 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.
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
- Gastroscopy; Gastric Cancer
- Being tested
- Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long), Administration of water before upper endoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)Drug
Administration of water before upper endoscopyDrug
| Study group | Role | What they receive |
|---|---|---|
| A - mucolytic solution | Experimental | 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. Receives: Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) |
| B - no intervention | No intervention | Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. |
| C - water | Placebo comparator | 100 ml of water given 30 minutes prior to upper endoscopy. Receives: Drug: Administration of water before 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 3 months
Secondary outcomes (3)
"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).
Measured: through study completion, an average of 3 months
Residual fluid in the stomach evaluated by blinded performing endoscopist
0-3 point scale
Measured: through study completion, an average of 3 months
Duration of endoscopy
time between introduction and withdrawal of the endoscopy
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroscopy; 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Falt, M.D., Ph.D., Vitkovice Hospital
- Investigators
- Premysl Falt, M.D., Ph.D., Principal investigator, Digestive Diseases Center, Vítkovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967094
- Sponsor's protocol ID
- DDC VN 09
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34158672
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial
- ClinicalTrials.gov ID
- NCT02967094
- Acronym / sponsor ID
- DDC VN 09
- Conditions
- Gastroscopy; Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - mucolytic solution | Experimental | Drug: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)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. |
| B - no intervention | No intervention | –Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy. |
| C - water | Placebo comparator | Drug: Administration of water before upper endoscopy100 ml of water given 30 minutes 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 (3 listed)
- age > 18 years
- signed informed consent
- diagnostic gastroscopy
Key exclusion criteria (6 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
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 |
|---|---|---|
| Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) | Drug | A - mucolytic solution |
| Administration 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 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).
3 secondary outcomes
"Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.
Time frame: 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
Duration of endoscopy
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Derived from this study: PubMed 34158672Stepan 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.
- 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.
Premysl Falt, M.D., Ph.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 Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long) and Administration of water before upper endoscopy in people with Gastroscopy; Gastric Cancer, 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 3 inclusion and 6 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 29 Nov 2016. 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 Premysl Falt, M.D., Ph.D. (+420595633 ext. 205, faltprem@centrum.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 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967094, which also lists 1 linked publication.
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 29 Nov 2016.