Intestinal Behcet DiseaseNCT06384391
Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease
An observational study of Intestinal Behcet Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Intestinal Behcet Disease
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2024to 31 Dec 2025
- 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 19 to 79 years
- All sexes
- Adult, Older adult
Study population: The investigators are enrolling ≥19 and <80-year-old patients who were diagnosed with intestinal Behcet's disease ≥3 months ago, whose disease activity is moderate or severe, and who visit Severance Hospital to be treated. The patients with bowel wall abnormality detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment are eligible. If there is no sonographic abnormality at week 0 that correlates the endoscopic and CT/MRE findings, the patient is not eligible. In addition, the patients who have complications not completely assessable with ultrasound and treating the complications is the treatment purpose; those who have enterocolitis attributable to the etiologies other than Behcet's disease; and those with morbidities that may affect the usual treatment of intestinal Behcet's disease are excluded.
Who may be able to join
- (1) The ≥19 and <80-year-old patients who diagnosed with intestinal Behcet's disease ≥3 months ago and whose disease activity is moderate or severe.
- Presence of abnormality in the bowel wall detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment
Who cannot join
- (1) Duration of intestinal Behcet's disease <3 months (2) Presence of complication that is not completely assessble with ultrasound and treating the complication is the treatment purpose (3) Absence of ultrasound finding at week 0 that correlates the abnormal findings detected in the endoscopic examination and CT/MRE (4) Suspected ulcerative colitis, Crohn's disease, unclassificed colitis, ischemic colitis, radiation proctitis, diverticular disease, or microscopic colitis (5) Evidence of active tuberculosis on chest radiograph cf. Those who were treated for ≥3 weeks for latent tuberculosis can participate in the study.
- Fecal stool positive for pathogenic bacteria or Clostiridum difficile toxin.
- Positive for human immunodeficient virus infection (8) Patients with hepatitis B or C or hepatic dysfunction (9) Patients who did not consent to the study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health system, Severance Hospital
Seoul, 03722
Hyun Kyung Yang, 82-2-2228-7400, hkyang@yuhs.ac
About this study
Official title: Ntestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Medical Treatment of Intestinal Behcet's Disease: Prospective Observational Study
Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.
While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment.
Read the detailed description
Design: Prospective, single-center, cohort, observational study. Methods: The patients with intestinal Behcet's disease who have detectable bowel wall abnormality on baseline ileocolonoscopic examination, CT or MRE, and ultrasound are enrolled before starting the medical treatment. Before and until 26 weeks after the treatment, Disease Activity Index for Intestinal Behcet's disease, intestinal ultrasound, ileocolonoscopic examination, MRE, serum C-reactive protein and fecal calprotectin examinations are done.
Purpose: To investigate the accuracies of intestinal ultrasound in identifying endoscopic and clinical remissions. Additionally, to investigate the accuracies of MRE in identifying endoscopic and clinical remissions and responses. Further assessment may include cross-sectional correlation analysis between the different examination results and regression analysis to assess whether baseline examination results can predict the long-term clinical outcomes.
Sample size: 55 patients. The primary outcome of this study, the diagnostic accuracy of intestinal ultrasound in identifying endoscopic remission, has not been previous studied or reported in patients with intestinal Behcet's disease. Therefore, the investigators adopted the prospective study results published in Journal of Gastroenterology and Hepatology Open in 2020 which reported the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of intestinal ultrasound in diagnosing endoscopically active disease in Crohn disease (Sathananthan D et al. JGH Open. 2020;4(2):273-9). In that study, the sensitivity, specificity, PPV, and NPV were 91%, 83%, 91%, and 83%, respectively, in 17 patients with Crohn's disease. In the data, the accuracy must have been either 82% (14/17) or 88% (15/17). Therefore, the investigators expect the accuracy in this study to be approximately 85%. Using confidence intervals for one proportion with Score (Wilson) formula, the sample size was calculated to achieve a 95% confidence interval width of 20% for the primary outcome. This calculation resulted in a sample size of 49. Considering an expected dropout rate of 10%, the investigators aim to include a total number of 55 patients.
- Conditions
- Intestinal Behcet Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment
The accuracy is defined as (the number of the patients with both endoscopic and ultrasound remissions + number of the patients with both endoscopic and ultrasound non-remissions)/total number of the patients
Measured: 26 weeks after initiation of the treatment.
Secondary outcomes (3)
Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment
The accuracy is defined as (the number of the patients with both clinical and ultrasound remissions + number of the patients with both clinical and ultrasound non-remissions)/total number of the patients.
Measured: 26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment
- The accuracy regarding endoscopic remission is defined as (the number of the patients with both endoscopic and magnetic resonance enterography remission + number of the patients with both endoscopic and magnetic resonance enterography non-remissions)/total number of the patients.
- The accuracy regarding clinical remission is defined as (the number of the patients with both clinical and magnetic resonance enterography remission + number of the patients with both clinical and magnetic resonance enterography non-remissions)/total number of the patients.
Measured: 26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment
- The accuracy regarding endoscopic response is defined as (the number of the patients with both endoscopic and magnetic resonance enterography response + number of the patients with both endoscopic and magnetic resonance enterography non-response)/total number of the patients.
- The accuracy regarding clinical response is defined as (the number of the patients with both clinical and magnetic resonance enterography response + number of the patients with both clinical and magnetic resonance enterography non-response)/total number of the patients.
Measured: 26 weeks after initiation of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Behcet DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384391
- Sponsor's protocol ID
- 4-2023-1730
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ntestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Medical Treatment of Intestinal Behcet's Disease: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06384391
- Acronym / sponsor ID
- 4-2023-1730
- Conditions
- Intestinal Behcet Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2024 (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.
Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.
While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment.
Detailed description
Design: Prospective, single-center, cohort, observational study. Methods: The patients with intestinal Behcet's disease who have detectable bowel wall abnormality on baseline ileocolonoscopic examination, CT or MRE, and ultrasound are enrolled before starting the medical treatment. Before and until 26 weeks after the treatment, Disease Activity Index for Intestinal Behcet's disease, intestinal ultrasound, ileocolonoscopic examination, MRE, serum C-reactive protein and fecal calprotectin examinations are done.
Purpose: To investigate the accuracies of intestinal ultrasound in identifying endoscopic and clinical remissions. Additionally, to investigate the accuracies of MRE in identifying endoscopic and clinical remissions and responses. Further assessment may include cross-sectional correlation analysis between the different examination results and regression analysis to assess whether baseline examination results can predict the long-term clinical outcomes.
Sample size: 55 patients. The primary outcome of this study, the diagnostic accuracy of intestinal ultrasound in identifying endoscopic remission, has not been previous studied or reported in patients with intestinal Behcet's disease. Therefore, the investigators adopted the prospective study results published in Journal of Gastroenterology and Hepatology Open in 2020 which reported the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of intestinal ultrasound in diagnosing endoscopically active disease in Crohn disease (Sathananthan D et al. JGH Open. 2020;4(2):273-9). In that study, the sensitivity, specificity, PPV, and NPV were 91%, 83%, 91%, and 83%, respectively, in 17 patients with Crohn's disease. In the data, the accuracy must have been either 82% (14/17) or 88% (15/17). Therefore, the investigators expect the accuracy in this study to be approximately 85%. Using confidence intervals for one proportion with Score (Wilson) formula, the sample size was calculated to achieve a 95% confidence interval width of 20% for the primary outcome. This calculation resulted in a sample size of 49. Considering an expected dropout rate of 10%, the investigators aim to include a total number of 55 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators are enrolling ≥19 and <80-year-old patients who were diagnosed with intestinal Behcet's disease ≥3 months ago, whose disease activity is moderate or severe, and who visit Severance Hospital to be treated. The patients with bowel wall abnormality detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment are eligible. If there is no sonographic abnormality at week 0 that correlates the endoscopic and CT/MRE findings, the patient is not eligible. In addition, the patients who have complications not completely assessable with ultrasound and treating the complications is the treatment purpose; those who have enterocolitis attributable to the etiologies other than Behcet's disease; and those with morbidities that may affect the usual treatment of intestinal Behcet's disease are excluded.
Key inclusion criteria (2 listed)
- (1) The ≥19 and <80-year-old patients who diagnosed with intestinal Behcet's disease ≥3 months ago and whose disease activity is moderate or severe.
- Presence of abnormality in the bowel wall detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment
Key exclusion criteria (3 listed)
- (1) Duration of intestinal Behcet's disease <3 months (2) Presence of complication that is not completely assessble with ultrasound and treating the complication is the treatment purpose (3) Absence of ultrasound finding at week 0 that correlates the abnormal findings detected in the endoscopic examination and CT/MRE (4) Suspected ulcerative colitis, Crohn's disease, unclassificed colitis, ischemic colitis, radiation proctitis, diverticular disease, or microscopic colitis (5) Evidence of active tuberculosis on chest radiograph cf. Those who were treated for ≥3 weeks for latent tuberculosis can participate in the study.
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
Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment
Time frame: 26 weeks after initiation of the treatment.
The accuracy is defined as (the number of the patients with both endoscopic and ultrasound remissions + number of the patients with both endoscopic and ultrasound non-remissions)/total number of the patients
3 secondary outcomes
Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment
Time frame: 26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment
Time frame: 26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment
Time frame: 26 weeks after initiation of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Related trials for Intestinal Behcet Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
RecruitingObservational study
Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
Behcet Disease, Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis
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.
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 Intestinal Behcet Disease, run by Yonsei University at 1 site in South Korea.
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 3 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 25 Apr 2024. 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 South Korea. 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 Hyun Kyung Yang (+82-2-2228-7400, hkyang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment (time frame: 26 weeks after initiation of the treatment.). 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 25 Apr 2024.