Oesophageal Motility Disorder Clinical Trial
Official title:
Correlation Between Clinical Signs and High-resolution Manometry Data in Children
| NCT number | NCT03662490 |
| Other study ID # | 2017-54 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2018 |
| Est. completion date | June 2021 |
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
| Status | Not yet recruiting |
| Enrollment | 1000 |
| Est. completion date | June 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Patients for whom the examination was a control of a previous examination. |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Des Hopitaux de Marseille | Marseille | Paca |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |