Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03829865
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Vasily Isakov, MD, PhD, AGAF, Russian Academy of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment
Healthy Diagnostic Test: High resolution esophageal manometry

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
Water-perfused HREM
Healthy volunteers examined with water-perfused high resolution esophageal manometry
Diagnostic Test: High resolution esophageal manometry
High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study

Solid-state HREM
Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter
Diagnostic Test: High resolution esophageal manometry
High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829865


Contacts
Layout table for location contacts
Contact: Sergey Morozov, MD, PhD +74996131091 morosoffsv@mail.ru

Locations
Layout table for location information
Russian Federation
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology Recruiting
Moscow, Russian Federation, 115446
Contact: Sergey Morozov, MD, PhD    +74996131091    84996131091@mail.ru   
Contact: Vasily Kropochev, MD    +74997943572      
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Layout table for investigator information
Study Chair: Vasily Isakov, MD, PhD Federal Research Center of Nutrition and Biotechnology
Principal Investigator: Sergey Morozov, MD, PhD Federal Research Center of Nutrition and Biotechnology

Layout table for additonal information
Responsible Party: Professor Vasily Isakov, MD, PhD, AGAF, MD, PhD, Professor, AGAF, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03829865     History of Changes
Other Study ID Numbers: OGIG-2019-1
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Depersonalized individual data may be shared upon the study completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 5 years
Access Criteria: by request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes