Inflammatory Bowel DiseasesNCT05223452
Role of Ultrasound in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
The aim of this article is to provide an extensive overview of the actual role of bowel ultrasound in the detection and follow-up of patients with chronic inflammatory bowel disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- UltraSound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to Jul 2023
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: all patients that come to assuit university hospital suffering from bowel disease no exclusion
Who may be able to join
- All patient reffered to radiology department for doing ultrasonography suspected to have bowel disease.
Who cannot join
- No patient excluded to do this process.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Intestinal Ultrasound in Inflammatory Bowel Disease in Correlation to Endoscopic Findings
The aim of this article is to provide an extensive overview of the actual role of bowel ultrasound in the detection and follow-up of patients with chronic inflammatory bowel disease
Read the detailed description
The inflammatory bowel disease is a chronic bowel disorder; it can involve the whole gastrointestinal tract, but its localization in the ileum or colon is most common. The reference standard for the diagnosis of inflammatory bowel disease is ileocolonoscopy with histologic assessment. Dan Carter, Lior H. Katz, Eytan Bardan, Eti Salomon, Shulamit Goldstein, Shomron Ben Horin, Uri Kopylov, and Rami Eliakim The reference standard for the detection of any complications is surgery. However, imaging techniques have an important role both in the detection/localization of C D and in the followup of C D patients. In the last few years, the technical development of ultrasound equipment, the advent of new technologies such as elastography and mostly the increased expertise of sonographers have boosted the role of bowel ultrasound in assessment of the gastrointestinal tract. In fact, bowel ultrasound is particularly attractive thanks to its widespread availability, non-invasiveness, low cost and good reproducibility, as it can be easily repeated during follow-up Clara Benedetta Conti , Mariangela Giunta , Daniele Gridavilla , Dario Conte , Mirella Fraquelli . Bowel ultrasound has become the first-line imaging technique for patients with suspected C rohn's disease because it is cheap ,less radiation effect ,it can be done more than one time for follow up these patient . Some signs, for example, bowel loop elasticity (i.e., the capability of the bowel wall to collapse on the bowel lumen and return to the original size and shape after manual compression and decompression) and compressibility at probe contact and peristalsis (usually impaired), are not specific, whereas other signs, such as the characteristics of the bowel wall, are more specific. Among the latter, the most important sign is bowel wall thickening (BWT) . Also important are bowel wall echo pattern characteristics (BWP) , the presence of any margin irregularity and the grade of vascularity at echo color Doppler or power Doppler . Other yet less frequent signs are the luminal alterations, such as the distension or any luminal stenosis. Other possible findings outside the bowel loop are mesenteric hypertrophy , enlarged mesenteric lymph nodes and free fluid in the abdominal cavity or among the bowel loops .
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- UltraSound
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraSoundDevice
we use prob that admit some of radiation to patient to see the organs inside the abdomen
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of ultrasound findings with endoscopic findings
analysis of ultrasound findings in patient and test if it can diagnose the different types of inflammatory bowel disease
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Mohamed Gad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223452
- Sponsor's protocol ID
- US IN IBD
- Status last verified
- Jan 2022
- First submitted
- 23 Oct 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andreoli A, Cerro P, Falasco G, Giglio LA, Prantera C. Role of ultrasonography in the diagnosis of postsurgical recurrence of Crohn's disease. Am J Gastroenterol. 1998 Jul;93(7):1117-21. doi: 10.1111/j.1572-0241.1998.00340.x.
PubMed 9672341Castiglione F, Bucci L, Pesce G, De Palma GD, Camera L, Cipolletta F, Testa A, Diaferia M, Rispo A. Oral contrast-enhanced sonography for the diagnosis and grading of postsurgical recurrence of Crohn's disease. Inflamm Bowel Dis. 2008 Sep;14(9):1240-5. doi: 10.1002/ibd.20469.
PubMed 18398896
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intestinal Ultrasound in Inflammatory Bowel Disease in Correlation to Endoscopic Findings
- ClinicalTrials.gov ID
- NCT05223452
- Acronym / sponsor ID
- US IN IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 4 Feb 2022 (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.
The aim of this article is to provide an extensive overview of the actual role of bowel ultrasound in the detection and follow-up of patients with chronic inflammatory bowel disease
Detailed description
The inflammatory bowel disease is a chronic bowel disorder; it can involve the whole gastrointestinal tract, but its localization in the ileum or colon is most common. The reference standard for the diagnosis of inflammatory bowel disease is ileocolonoscopy with histologic assessment. Dan Carter, Lior H. Katz, Eytan Bardan, Eti Salomon, Shulamit Goldstein, Shomron Ben Horin, Uri Kopylov, and Rami Eliakim The reference standard for the detection of any complications is surgery. However, imaging techniques have an important role both in the detection/localization of C D and in the followup of C D patients. In the last few years, the technical development of ultrasound equipment, the advent of new technologies such as elastography and mostly the increased expertise of sonographers have boosted the role of bowel ultrasound in assessment of the gastrointestinal tract. In fact, bowel ultrasound is particularly attractive thanks to its widespread availability, non-invasiveness, low cost and good reproducibility, as it can be easily repeated during follow-up Clara Benedetta Conti , Mariangela Giunta , Daniele Gridavilla , Dario Conte , Mirella Fraquelli . Bowel ultrasound has become the first-line imaging technique for patients with suspected C rohn's disease because it is cheap ,less radiation effect ,it can be done more than one time for follow up these patient . Some signs, for example, bowel loop elasticity (i.e., the capability of the bowel wall to collapse on the bowel lumen and return to the original size and shape after manual compression and decompression) and compressibility at probe contact and peristalsis (usually impaired), are not specific, whereas other signs, such as the characteristics of the bowel wall, are more specific. Among the latter, the most important sign is bowel wall thickening (BWT) . Also important are bowel wall echo pattern characteristics (BWP) , the presence of any margin irregularity and the grade of vascularity at echo color Doppler or power Doppler . Other yet less frequent signs are the luminal alterations, such as the distension or any luminal stenosis. Other possible findings outside the bowel loop are mesenteric hypertrophy , enlarged mesenteric lymph nodes and free fluid in the abdominal cavity or among the bowel loops .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients that come to assuit university hospital suffering from bowel disease no exclusion
Key inclusion criteria (1 listed)
- All patient reffered to radiology department for doing ultrasonography suspected to have bowel disease.
Key exclusion criteria (1 listed)
- No patient excluded to do this process.
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 |
|---|---|---|
| UltraSoundwe use prob that admit some of radiation to patient to see the organs inside the abdomen | Device | – |
Primary outcome
comparison of ultrasound findings with endoscopic findings
Time frame: baseline
analysis of ultrasound findings in patient and test if it can diagnose the different types of inflammatory bowel disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 9672341Andreoli A, Cerro P, Falasco G, Giglio LA, Prantera C. Role of ultrasonography in the diagnosis of postsurgical recurrence of Crohn's disease. Am J Gastroenterol. 1998 Jul;93(7):1117-21. doi: 10.1111/j.1572-0241.1998.00340.x.
- Background: PubMed 18398896Castiglione F, Bucci L, Pesce G, De Palma GD, Camera L, Cipolletta F, Testa A, Diaferia M, Rispo A. Oral contrast-enhanced sonography for the diagnosis and grading of postsurgical recurrence of Crohn's disease. Inflamm Bowel Dis. 2008 Sep;14(9):1240-5. doi: 10.1002/ibd.20469.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
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 1 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 shrouk gad (01028565525, shroukgad863@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of ultrasound findings with endoscopic findings (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223452, which also lists 2 linked publications.
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 4 Feb 2022.