InflammationNCT03788824
Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE
An observational study of Inflammation, run by Shandong University at 1 site in China.
Trial summary
The aim:1) To test the correlation of pCLE-obtained features with histological findings in UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To test the accuracy of the investigators previously proposed simplified four-grade classification system of crypt architecture in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammation
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Who may be able to join
- Male or Female aged 18-80;
- patients previously or in-process diagnosed as Ulcerative Colitis
Who cannot join
- Patients with gastrectomy, acute GI bleeding, and advanced esophageal cancer;
- Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), lactation, food retention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
- Inability to provide informed consent and other situations that could interfere with the examination protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD. PhD., 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
Official title: Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy
The aim:1) To test the correlation of pCLE-obtained features with histological findings in UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To test the accuracy of the investigators previously proposed simplified four-grade classification system of crypt architecture in evaluating inflammation activity in UC by pCLE.
Read the detailed description
Patients with acute inflammatory infiltrates seen on histological assessment are more likely to experience relapse than are those without infiltrates,studies suggest that severity of inflammation is a risk factor for colorectal neoplasia in UC.
The assessment of inflammation activity by conventional colonoscopy is inaccurate in the prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our previous study, we confirmed a simplified four-grade classification system of crypt architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt abscess) by eCLE in predicting acute inflammation, and found a good correlation with histology. In this study, the investigators aimed to test the accuracy of the proposed tne four-grade classification system in evaluating inflammation activity in UC by pCLE.
- Conditions
- Inflammation
- Keywords
- Ulcerative Colitis, probe-based Confocal Laser Endoscopy, Inflammation Activity, Histology
- Medical subject headings
- Inflammation, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pCLE group | pCLE is used to distinguish the inflammation activity of UC, and compared with histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.
Recruited more than 100 UC patients,pCLE diagnostic criteria was the four-grades crypt architecture classification system ( inactive cases with Grade A or B, active with Grade C or D), histological assessment according to the Geboes Index ( inactive disease with Geboes index ≤ 3.0; active disease with a index > 3.0). Using Spearman's text, calculating the corelation between pCLE real-time finding and the Geboes index, if p<0.05, it means a strong corelation,vice versa. Also for the offline diagnosis.
Also calculate the corelation between white-light colonoscopy (Baron Score) and histopathology.
Measured: 2 years
Secondary outcomes (1)
Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.
Assessment of interobserver variability of pCLE was conducted in a randomized pCLE videos' order by two independent investigators. After a 2-week interval, all pCLE videos were reassessed by the two investigators to evaluate the intraobserver agreement.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study startJun 2014
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD. PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788824
- Sponsor's protocol ID
- 2014SDU-QILU-G05
- Status last verified
- Dec 2018
- First submitted
- 13 Nov 2014
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT03788824
- Acronym / sponsor ID
- 2014SDU-QILU-G05
- Conditions
- Inflammation
- Keywords
- Ulcerative Colitis, probe-based Confocal Laser Endoscopy, Inflammation Activity, Histology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 28 Dec 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.
The aim:1) To test the correlation of pCLE-obtained features with histological findings in UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To test the accuracy of the investigators previously proposed simplified four-grade classification system of crypt architecture in evaluating inflammation activity in UC by pCLE.
Detailed description
Patients with acute inflammatory infiltrates seen on histological assessment are more likely to experience relapse than are those without infiltrates,studies suggest that severity of inflammation is a risk factor for colorectal neoplasia in UC.
The assessment of inflammation activity by conventional colonoscopy is inaccurate in the prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our previous study, we confirmed a simplified four-grade classification system of crypt architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt abscess) by eCLE in predicting acute inflammation, and found a good correlation with histology. In this study, the investigators aimed to test the accuracy of the proposed tne four-grade classification system in evaluating inflammation activity in UC by pCLE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE group | – | –pCLE is used to distinguish the inflammation activity of UC, and compared with histology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Key inclusion criteria (2 listed)
- Male or Female aged 18-80;
- patients previously or in-process diagnosed as Ulcerative Colitis
Key exclusion criteria (3 listed)
- Patients with gastrectomy, acute GI bleeding, and advanced esophageal cancer;
- Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), lactation, food retention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
- Inability to provide informed consent and other situations that could interfere with the examination protocol.
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
A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.
Time frame: 2 years
Recruited more than 100 UC patients,pCLE diagnostic criteria was the four-grades crypt architecture classification system ( inactive cases with Grade A or B, active with Grade C or D), histological assessment according to the Geboes Index ( inactive disease with Geboes index ≤ 3.0; active disease with a index > 3.0). Using Spearman's text, calculating the corelation between pCLE real-time finding and the Geboes index, if p<0.05, it means a strong corelation,vice versa. Also for the offline diagnosis. Also calculate the corelation between white-light colonoscopy (Baron Score) and histopathology.
1 secondary outcome
Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 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.
Yanqing Li, MD. PhD. principal investigator
Qilu Hospital of Shandong University
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 Inflammation, run by Shandong University at 1 site in China.
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 28 Dec 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 China. 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 Yangqing li, PhD. MD (86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC. (time frame: 2 years). 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 28 Dec 2018.