Oesophageal Motility DisorderNCT03662490
Correlation Between Clinical Signs and High-resolution Manometry Data in Children
An observational study of Oesophageal Motility Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Oesophageal Motility Disorder
- What is being tested?
- High resolution oesophageal manometry
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2018to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
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).
Who may be able to join
- 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).
Who cannot join
- Patients for whom the examination was a control of a previous examination.
Trial locations and contacts
1 site in 1 country.
MARINE JUZAUD, MD contact
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
MARINE JUZAUD, MD, MARINE.JUZAUD@ap-hm.fr
About this study
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.
Read more
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
Read the 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
- Being tested
- High resolution oesophageal manometry
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution oesophageal manometryDevice
High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.
| Study group | Role | What they receive |
|---|---|---|
| patient | Patient who performed a High resolution oesophageal manometry (HRM) for the diagnosis of oesophageal motility disorder. Receives: Device: High resolution oesophageal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal Motility DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662490
- Sponsor's protocol ID
- 2017-54
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical Signs and High-resolution Manometry Data in Children
- ClinicalTrials.gov ID
- NCT03662490
- Acronym / sponsor ID
- 2017-54
- Conditions
- Oesophageal Motility Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Device: High resolution oesophageal manometryPatient who performed a High resolution oesophageal manometry (HRM) for the diagnosis of oesophageal motility disorder. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients for whom the examination was a control of a previous examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution oesophageal manometryHigh resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder. | Device | patient |
Primary outcome
number of clinical sign
Time frame: one week
Symptoms include: Dysphagia, Swallowing Disorders, Food Blockages, Oral Disorders, Vomiting, GERD, Anorexia, Weight Loss, Belching, Respiratory Exacerbations, and Back Sternal Pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARINE JUZAUD, MD contact
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Motility Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARINE JUZAUD, MD (MARINE.JUZAUD@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of clinical sign (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.