Crohn DiseaseECHOCROHNNCT03439826
Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease
An observational study of Crohn Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Observational study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 1 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for Crohn's disease
Who may be able to join
- Patients followed for Crohn's disease;
- Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
- Benefiting from an abdominal ultrasound as part of their usual follow-up;
- Not having expressed his opposition to participate in the study.
Who cannot join
- Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease (ECHOCROHN)
Observational study
Read the detailed description
Crohn's disease is a chronic inflammatory disease of the intestine (IBD), evolving with varying periods of remissions and relapses, characterized by segmental inflammation of the digestive tract, which can be complicated by stenosis, fistulas or even digestive cancers.
The emergence of effective therapeutic strategies has led to the adoption of more ambitious therapeutic objectives that have no longer the improvement of symptoms but a complete cicatrization of the intestinal mucosa as an objective.
The disadvantage of the latter is the need for its evaluation by ilo-colonoscopy, "gold-standard", invasive, not without risks (perforation, anesthesia, hemorrhage), requiring colonic preparation and hospitalization.
In this context, the use of non-invasive markers performed in routine practice (hemogram, VS, CRP, fibrinogen, fecal calprotectin, abdominal ultrasound), predictive of this endoscopic mucosal healing, is a necessity to improve the tolerance of follow-up and allow better adherence by the patient of the therapeutic project. A decrease in health costs could also be associated with the use of these markers.
Abdominal ultrasound is an accessible, inexpensive, non-invasive and non-irradiating imaging medium. It is very useful and has proved its effectiveness in monitoring Crohn's disease to evaluate the activity of the disease in order to predict mucosal healing and to detect complications (stenosis, fistula, abscess) (1, 2, 3). However, especially for the study of the small intestine this act is known to be very dependent on the operator and the conditions of examination (echogenicity of the patient). In addition, few objective criteria have been described in the literature for the study of Crohn's disease (2, 3).
A recent study under submission has developed an ultrasound score of Crohn's disease activity, which through the study of each segment (distal ileum, right colon / transverse / left, sigmoid) using 14 criteria , allowed to rule on the activity of the disease and thus to predict mucosal healing. In this study, which concerned 48 patients, ultrasound scans were performed by radiologists experienced in abdominal pathology. This score was very easy to use and powerful to study the disease activity of each segment with 2 parameters in particular: parietal thickness and changes in fat.
It therefore seems necessary to confirm the simplicity of this ultrasound score in a validation cohort to: in particular to study the inter-observer reproducibility so as to be able to extend the use of this score to non-specialist radiologists.
- Conditions
- Crohn Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity
These criteria are to be found on each segment: terminal ileum, right colon, transverse colon, left colon and sigmoid.
- Normal appearance: yes / no
- Maximum parietal wall thickness (mm)
- parietal differentiation: yes / no
- Ulceration: yes / no
- Fistula: yes / no
- Infiltration of peripheral fat: yes / no
- Sclerolipomatosis: yes / no
- Stenosis: yes / no
Criterion for the entire abdominal cavity :
- Mesangular ganglion> 5mm: yes / no
- Intraperitoneal fluid effusion: yes / no Abdominal abscess: yes / no
- dilated handles: yes / no
- Total length of reach (in mm)
- Distance to the valve
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start13 Feb 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Bouguen, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439826
- Sponsor's protocol ID
- 35RC18_3094_ECHOCROHN
- Acronym
- ECHOCROHN
- Status last verified
- Jun 2019
- First submitted
- 13 Feb 2018
- Last updated
- 19 Jun 2019
- 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 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease (ECHOCROHN)
- ClinicalTrials.gov ID
- NCT03439826
- Acronym / sponsor ID
- ECHOCROHN / 35RC18_3094_ECHOCROHN
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Feb 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.
Observational study
Detailed description
Crohn's disease is a chronic inflammatory disease of the intestine (IBD), evolving with varying periods of remissions and relapses, characterized by segmental inflammation of the digestive tract, which can be complicated by stenosis, fistulas or even digestive cancers.
The emergence of effective therapeutic strategies has led to the adoption of more ambitious therapeutic objectives that have no longer the improvement of symptoms but a complete cicatrization of the intestinal mucosa as an objective.
The disadvantage of the latter is the need for its evaluation by ilo-colonoscopy, "gold-standard", invasive, not without risks (perforation, anesthesia, hemorrhage), requiring colonic preparation and hospitalization.
In this context, the use of non-invasive markers performed in routine practice (hemogram, VS, CRP, fibrinogen, fecal calprotectin, abdominal ultrasound), predictive of this endoscopic mucosal healing, is a necessity to improve the tolerance of follow-up and allow better adherence by the patient of the therapeutic project. A decrease in health costs could also be associated with the use of these markers.
Abdominal ultrasound is an accessible, inexpensive, non-invasive and non-irradiating imaging medium. It is very useful and has proved its effectiveness in monitoring Crohn's disease to evaluate the activity of the disease in order to predict mucosal healing and to detect complications (stenosis, fistula, abscess) (1, 2, 3). However, especially for the study of the small intestine this act is known to be very dependent on the operator and the conditions of examination (echogenicity of the patient). In addition, few objective criteria have been described in the literature for the study of Crohn's disease (2, 3).
A recent study under submission has developed an ultrasound score of Crohn's disease activity, which through the study of each segment (distal ileum, right colon / transverse / left, sigmoid) using 14 criteria , allowed to rule on the activity of the disease and thus to predict mucosal healing. In this study, which concerned 48 patients, ultrasound scans were performed by radiologists experienced in abdominal pathology. This score was very easy to use and powerful to study the disease activity of each segment with 2 parameters in particular: parietal thickness and changes in fat.
It therefore seems necessary to confirm the simplicity of this ultrasound score in a validation cohort to: in particular to study the inter-observer reproducibility so as to be able to extend the use of this score to non-specialist radiologists.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for Crohn's disease
Key inclusion criteria (4 listed)
- Patients followed for Crohn's disease;
- Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
- Benefiting from an abdominal ultrasound as part of their usual follow-up;
- Not having expressed his opposition to participate in the study.
Key exclusion criteria (1 listed)
- Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity
Time frame: Baseline
These criteria are to be found on each segment: terminal ileum, right colon, transverse colon, left colon and sigmoid. * Normal appearance: yes / no * Maximum parietal wall thickness (mm) * parietal differentiation: yes / no * Ulceration: yes / no * Fistula: yes / no * Infiltration of peripheral fat: yes / no * Sclerolipomatosis: yes / no * Stenosis: yes / no Criterion for the entire abdominal cavity : * Mesangular ganglion> 5mm: yes / no * Intraperitoneal fluid effusion: yes / no Abdominal abscess: yes / no * dilated handles: yes / no * Total length of reach (in mm) * Distance to the valve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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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.
Guillaume Bouguen principal investigator
Rennes University Hospital
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 Crohn Disease, run by Rennes University Hospital 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 4 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: finished, as of the sponsor's last update on 19 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity (time frame: Baseline). 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 19 Jun 2019.