Small Bowel Crohn's DiseaseNCT01555437
Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)
An observational study of Small Bowel Crohn's Disease, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical presentation can vary considerably. Patients are frequently assessed by capsule endoscopy (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between CE scoring index (CESI)… Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Small Bowel Crohn's Disease
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Feb 2011
- 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients underwent CE examination (described below), and only those patients for whom complete CE examination (in which the capsule reached the cecum within the CE test time) was achieved were retained for study.
Who may be able to join
- patients with known SBCD or newly diagnosed SBCD
- those patients for whom complete CE examination (in which the capsule
- reached the cecum within the CE test time) was achieved were retained for study
Who cannot join
- incomplete CE examination
- infectious enterocolitis
- symptoms related to perianal penetrating disease
- gastrointestinal cancer
- ulcerative colitis
- indeterminate colitis
Show all 10Show fewer
- history of extensive small bowel resection
- known CD of the upper gastrointestinal tract or colon
- intake of non-steroidal anti-inflammatory drugs (NSAIDs) (more than two tablets per week)
- pregnancy
About this study
Official title: Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease
Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical presentation can vary considerably. Patients are frequently assessed by capsule endoscopy (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between CE scoring index (CESI), biological markers, and disease activity indices remain undefined.
Methods: A prospective study was conducted between October 2008 and February 2011 on 58 established SBCD patients and suspected patients who received a definitive SBCD diagnosis during study. Patients underwent complete CE, and were scored according to the CESI (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the patients underwent CE with scoring for CESI, HBI, and CRP.
Read the detailed description
Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of <135. Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.
HBI HBI was used to assess the clinical disease activity. Patients with HBI >4 were considered to have clinically active disease.[7]
Blood analysis At the time of CE, patients provided a blood sample for measurement of hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men, 140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: <8 mg/L) were determined by routine laboratory tests.
- Conditions
- Small Bowel Crohn's Disease
- Keywords
- capsule endoscopy scoring index, Harvey-Bradshaw index, C-reactive protein, serum albumin, hemoglobin
What is being measured
The primary outcome is the main question the study is designed to answer.
Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01).
Measured: 2012.06
The correlation between CESI and CRP was moderate (r=0.58, p<0.01).
Measured: 2012.07
The median CRP value was significantly higher in patients with moderate-severe CESI, compared to the mild group (22.60±16.79 mg/L vs. 11.88±8.39 mg/L, p<0.01).
Measured: 2012.08
Changes between baseline and follow-up CESI failed to correlate with the delta-HBI or delta-CRP (both, p>0.05).
Measured: 2012.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhizheng Ge, MD. Ph.D, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555437
- Sponsor's protocol ID
- rjyyxhk0306
- Status last verified
- Nov 2013
- First submitted
- 13 Mar 2012
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT01555437
- Acronym / sponsor ID
- rjyyxhk0306
- Conditions
- Small Bowel Crohn's Disease
- Keywords
- capsule endoscopy scoring index, Harvey-Bradshaw index, C-reactive protein, serum albumin, hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Mar 2012 (estimated)
- 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: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical presentation can vary considerably. Patients are frequently assessed by capsule endoscopy (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between CE scoring index (CESI), biological markers, and disease activity indices remain undefined.
Methods: A prospective study was conducted between October 2008 and February 2011 on 58 established SBCD patients and suspected patients who received a definitive SBCD diagnosis during study. Patients underwent complete CE, and were scored according to the CESI (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the patients underwent CE with scoring for CESI, HBI, and CRP.
Detailed description
Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of <135. Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.
HBI HBI was used to assess the clinical disease activity. Patients with HBI >4 were considered to have clinically active disease.[7]
Blood analysis At the time of CE, patients provided a blood sample for measurement of hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men, 140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: <8 mg/L) were determined by routine laboratory tests.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients underwent CE examination (described below), and only those patients for whom complete CE examination (in which the capsule reached the cecum within the CE test time) was achieved were retained for study.
Key inclusion criteria (3 listed)
- patients with known SBCD or newly diagnosed SBCD
- those patients for whom complete CE examination (in which the capsule
- reached the cecum within the CE test time) was achieved were retained for study
Key exclusion criteria (10 listed)
- incomplete CE examination
- infectious enterocolitis
- symptoms related to perianal penetrating disease
- gastrointestinal cancer
- ulcerative colitis
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
Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01).
Time frame: 2012.06
The correlation between CESI and CRP was moderate (r=0.58, p<0.01).
Time frame: 2012.07
The median CRP value was significantly higher in patients with moderate-severe CESI, compared to the mild group (22.60±16.79 mg/L vs. 11.88±8.39 mg/L, p<0.01).
Time frame: 2012.08
Changes between baseline and follow-up CESI failed to correlate with the delta-HBI or delta-CRP (both, p>0.05).
Time frame: 2012.09
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 Nov 2013.
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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.
Zhizheng Ge, MD. Ph.D principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Crohn's Disease, run by Shanghai Jiao Tong University School of Medicine.
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 3 inclusion and 10 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 Nov 2013. 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?
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?
Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01). (time frame: 2012.06). The study lists 4 primary outcomes in all. 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 Nov 2013.