HealthyNCT03829865
Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
An observational study of Healthy, run by Russian Academy of Medical Sciences at 3 sites in Russia.
Trial summary
High resolution esophageal manometry normative values are still need to be studied in different populations and with the use of solid-state and water-perfused systems. There has been no study on the subject in healthy Russian population yet. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High resolution esophageal manometry
- How many people
- 80 participants
- Where
- 3 sitesRussia
- Study dates
- 4 Feb 2019to 31 Dec 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is aimed to evaluate high resolution esophageal motility parameters in subjects who have no signs of any esophageal disorders and are residents of Russia
Inclusion Criteria (all points are necessary for inclusion):
- Willingness to participate on the basis of signed informed consent form;
- Patients of both sexes, aged 18 to 65 years inclusive;
- Permanent residence in the Russian Federation;
- Absence of esophageal diseases, confirmed by the results of clinical and instrumental examination
- Ability to follow instructions during high-resolution esophageal manometry procedure
Exclusion Criteria (patient is not eligible when at least one exclusion criterion is met):
- diseases of the esophagus (any condition on the basis of clinical and / or instrumental examination, including: complaints of heartburn, belching, difficulty to swallow solid and/or liquid food;
- any surgical intervention on the gastrointestinal tract and / or chest organs in medical history;
- solid organ transplantation in medical history with the exception of a corneal transplant and surgery to replace the lens of the eye;
- any oncology of any localization except for skin cancer in situ in the medical history;
- any decompensated diseases of any organs and systems, which, in the opinion of the researcher, makes it impossible to carry out the procedure of esophageal manometry of high resolution or if the procedure may cause the risk of deterioration of the patient's condition;
- any condition, clinical and laboratory signs of alcohol abuse (abuse will be assessed in the case of male subjects consuming more than 30 g of pure alcohol per day and using more than 20 g of pure alcohol per day by female subjects;
- any illegal drug use, current or past;
- use of concomitant medications that can affect esophageal motility including, but not limited to: calcium channel blockers, metoclopramide, m-cholinolytics, domperidone, erythromycin, nitrates, tricyclic antidepressants, opiates, beta-blockers, beta-adrenomimetics, alcohol. The duration of the period of non-use of these drugs should provide sufficient time for the complete cessation of their pharmacological action, but not less than two half-life.
- pregnant or breastfeeding women
- any condition making impossible to perform high resolution esophageal manometry (previously known poor tolerability of the procedure; narrow nasal passages; significant curvature of the nasal septum etc).
Trial locations and contacts
3 sites in 1 country.
Russia3 sites, 3 recruiting
- Recruiting
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, 115446
Sergey Morozov, MD, PhD, +74996131091, 84996131091@mail.ru
- Recruiting
Moscow clinical hospital #31
Moscow, 119415
Valeria O Kaibysheva, MD, PhD, +79160206727, valeriakai@mail.ru
- Recruiting
Pavlov First Saint Petersburg State Medical University. Endoscopy Department
Saint Petersburg, 197022
Alexandr A Smirnov, MD, PhD, +78005507225, smirnov-1959@yandex.ru
Maya M Kiriltseva, MD, PhD, +78005507225, kiriltseva@mail.ru
About this study
High resolution esophageal manometry normative values are still need to be studied in different populations and with the use of solid-state and water-perfused systems. There has been no study on the subject in healthy Russian population yet.
Read the detailed description
High-resolution esophageal manometry (HREM) is the current modality used to evaluate esophageal motility. There are 2 types of system: water-perfused system that is cheaper to maintain and a solid-state system that is considered to be more sensitive. According to the data obtained in the study of 400 patients and 75 controls by J Pandolfino et al it was proposed to use a common algorithm of HREM data interpretation and the normative values of the parameters used to interpret the color plots of HREM. This formed the basis for the first version of the currently used HREM reporting algorithm and classification of esophageal motility disorders called Chicago Classification (CC). To date, this classification has been updated several times by the International Working Group based on the recently published data. The Working group stated that the proposed normative values still need to be widely studied for each HREM system and in different populations. Some studies has been published recently on the normative values of HREM in different countries (predominantly in the US, in some European countries, Korea, India and China. But there has been no study on the subject in Russia still.
- Conditions
- Healthy
- Being tested
- High resolution esophageal manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution esophageal manometryDiagnostic test
High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study
| Study group | Role | What they receive |
|---|---|---|
| Water-perfused HREM | Healthy volunteers examined with water-perfused high resolution esophageal manometry Receives: Diagnostic Test: High resolution esophageal manometry | |
| Solid-state HREM | Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter Receives: Diagnostic Test: High resolution esophageal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IRP
Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation
Measured: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean DCI
distal contractile integral - Amplitude x duration x length (mmHg x s x cm) of the distal esophageal contraction exceeding 20 mmHg from the transition zone to the proximal margin of the LES
Measured: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean DL
distal latency - Interval between UES relaxation and the contractile deceleration point
Measured: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Mean upper esophageal sphincter mean resting pressure
mean pressure of the upper esophageal sphincter
Measured: mean value based on 30 seconds measurement of a subject
Mean lower esophageal sphincter mean resting pressure
mean pressure of the upper esophageal sphincter
Measured: mean value based on 30 seconds measurement of a subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start4 Feb 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasily Isakov, Russian Academy of Medical Sciences
- Investigators
- Vasily Isakov, MD, PhD, Study chair, Federal Research Center of Nutrition and BiotechnologySergey Morozov, MD, PhD, Principal investigator, Federal Research Center of Nutrition and Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829865
- Sponsor's protocol ID
- OGIG-2019-1
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Depersonalized individual data may be shared upon the study completion.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
- ClinicalTrials.gov ID
- NCT03829865
- Acronym / sponsor ID
- OGIG-2019-1
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Feb 2019 (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.
High resolution esophageal manometry normative values are still need to be studied in different populations and with the use of solid-state and water-perfused systems. There has been no study on the subject in healthy Russian population yet.
Detailed description
High-resolution esophageal manometry (HREM) is the current modality used to evaluate esophageal motility. There are 2 types of system: water-perfused system that is cheaper to maintain and a solid-state system that is considered to be more sensitive. According to the data obtained in the study of 400 patients and 75 controls by J Pandolfino et al it was proposed to use a common algorithm of HREM data interpretation and the normative values of the parameters used to interpret the color plots of HREM. This formed the basis for the first version of the currently used HREM reporting algorithm and classification of esophageal motility disorders called Chicago Classification (CC). To date, this classification has been updated several times by the International Working Group based on the recently published data. The Working group stated that the proposed normative values still need to be widely studied for each HREM system and in different populations. Some studies has been published recently on the normative values of HREM in different countries (predominantly in the US, in some European countries, Korea, India and China. But there has been no study on the subject in Russia still.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water-perfused HREM | – | Diagnostic Test: High resolution esophageal manometryHealthy volunteers examined with water-perfused high resolution esophageal manometry |
| Solid-state HREM | – | Diagnostic Test: High resolution esophageal manometryHealthy volunteers examined with high resolution esophageal manometry with solid-state catheter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is aimed to evaluate high resolution esophageal motility parameters in subjects who have no signs of any esophageal disorders and are residents of Russia
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 |
|---|---|---|
| High resolution esophageal manometryHigh resolution esophageal manometry will be performed to eligible subjects willing to participate in the study | Diagnostic test | Solid-state HREM, Water-perfused HREM |
Primary outcome
Mean IRP
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation
Mean DCI
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
distal contractile integral - Amplitude x duration x length (mmHg x s x cm) of the distal esophageal contraction exceeding 20 mmHg from the transition zone to the proximal margin of the LES
Mean DL
Time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
distal latency - Interval between UES relaxation and the contractile deceleration point
Mean upper esophageal sphincter mean resting pressure
Time frame: mean value based on 30 seconds measurement of a subject
mean pressure of the upper esophageal sphincter
Mean lower esophageal sphincter mean resting pressure
Time frame: mean value based on 30 seconds measurement of a subject
mean pressure of the upper esophageal sphincter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: Yes. Depersonalized individual data may be shared upon the study completion.
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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.
Vasily Isakov, MD, PhD study chair
Federal Research Center of Nutrition and Biotechnology
Sergey Morozov, MD, PhD principal investigator
Federal Research Center of Nutrition and Biotechnology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Russian Academy of Medical Sciences at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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. 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 Sergey Morozov, MD, PhD (+74996131091, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IRP (time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)). The study lists 5 primary outcomes in all. 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 26 Apr 2021.