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Correlation Between Clinical Signs and High-resolution Manometry Data in Children

NCT03662490 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2018-09-18

No results posted yet for this study

Summary

High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.

Standard esophageal manometry has been replaced since 2000 by high resolution manometry. This one allows a more precise study with a spatio-temporal representation of the esophageal pressure values as well as an easier realization with in particular a better tolerance of the examination which is important in pediatrics.

Over a period of 10 years only a dozen studies were conducted in children. No study to date has evaluated the global place of MHR in current practice in children across all indications.

The indications that lead to the realization of a manometry in children are given by some experts but there is currently no clinical study to define the sensitivities, specificity and predictive values of clinical symptoms leading to the completion of this examination and endoscopic signs found upstream.

In addition, the link between certain underlying conditions and the manometric result has never been evaluated.

II / Objective: The objective of our study is to calculate the sensitivity, the specificity and the predictive values of each clinical and endoscopic sign according to the manometric result found and this by age group. The goal is to better define the predictive signs of the selected manometric diagnoses and therefore the indications to remember in the child.

III / Methodology:

Bi-centric retrospective collection of data on patient records in Marseille and Lille. Collection dates: from 2012 (beginning of high resolution manometry in Marseille and Lille) to December 2016.

The clinical and endoscopic signs selected will be decided a priori by an expert committee consisting of 2 adult gastroenterologists specializing in manometry, 1 pediatrician specialist in manometry, and 3 gastro-pediatricians.

Inclusion Criteria: All minor patients (\<18 years old) referred for 1 st high-resolution manometry (or 2 nd or more examination if performed in the presence of a new symptom).

Number of subjects planned: all the patients who had a manometry (about 300 patients) over the given period

Conditions

  • Oesophageal Motility Disorder

Interventions

DEVICE

High resolution oesophageal manometry

High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • EMILIE GARRIDO PRADALIE · APHM

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662490 on ClinicalTrials.gov