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

NCT03662490 | Unknown

• 1 other identifier: 2017-54
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• number of clinical sign

  Symptoms include: Dysphagia, Swallowing Disorders, Food Blockages, Oral Disorders, Vomiting, GERD, Anorexia, Weight Loss, Belching, Respiratory Exacerbations, and Back Sternal Pain.

  one week

Study Arms (1)

patient

Patient who performed a High resolution oesophageal manometry (HRM) for the diagnosis of oesophageal motility disorder.

Device: High resolution oesophageal manometry

Interventions

High resolution oesophageal manometry DEVICE

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

patient

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All minor patients (\<18 years old)
• Referred for 1 st high-resolution manometry (or 2 nd or more examination if performed in front of a new symptom).

You may not qualify if:

• Patients for whom the examination was a control of a previous examination.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

MARINE JUZAUD, MD

CONTACT

MARINE.JUZAUD@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

FR (1)