NCT03662490

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Detailed description

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. They focused on the technical aspects of the realization but especially of the interpretation of the examination or on specific pathologies well described: the atresia of the esophagus and achalasia. As a result, 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

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

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2018-09-07
• Last updated: 2018-09-18

Locations

1 site across 1 country: France