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

NCT03829865 | Unknown DMC FDA Device

• 1 other identifier: OGIG-2019-1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  mean value based on 30 seconds measurement of a subject

• Mean lower esophageal sphincter mean resting pressure

  mean pressure of the upper esophageal sphincter

  mean value based on 30 seconds measurement of a subject

Study Arms (2)

Water-perfused HREM

Healthy volunteers examined with water-perfused high resolution esophageal manometry

Diagnostic Test: High resolution esophageal manometry

Solid-state HREM

Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter

Diagnostic Test: High resolution esophageal manometry

Interventions

High resolution esophageal manometry DIAGNOSTIC_TEST

High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study

Solid-state HREM; Water-perfused HREM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (3)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, 115446, Russia

RECRUITING

Moscow clinical hospital #31

Moscow, 119415, Russia

RECRUITING

Pavlov First Saint Petersburg State Medical University. Endoscopy Department

Saint Petersburg, 197022, Russia

RECRUITING

Study Officials

• Vasily Isakov, MD, PhD

  Federal Research Center of Nutrition and Biotechnology

  STUDY CHAIR

• Sergey Morozov, MD, PhD

  Federal Research Center of Nutrition and Biotechnology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Morozov, MD, PhD

CONTACT

+74996131091; morosoffsv@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, AGAF

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: February 4, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years
• Access Criteria: by request

Locations

RU (3)