Flow DeterminationNCT02595151
Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
An observational study of Flow Determination, run by Shandong University at 1 site in China.
Trial summary
The morphologic change of microvessels has the clinical value to distinguish cancerous from non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic gastritis and GIM; then evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Flow Determination
- What is being tested?
- CLE
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. 94 patients were eligible for analysis (50 males and 44 females; average age 53 years, range 22-80 years).
Who may be able to join
- Male or Female aged 18-80 ;
- Those fulfilling the criteria of GIM according to the study by Yuting Guo et al were included.
Who cannot join
- patients younger than 18 years or older than 80 years;
- finding of acute GI bleeding, gastrectomy or known upper gastrointestinal cancer;
- unwillingness to participate in this study;
- contraindications to CLE, such as fluorescein allergy, hepatic or renal dysfunction, jaundice, pregnancy and/or breast feeding, coagulopathy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, PhD, 15588818685 ext. 15588818685, xiulizuo@gmail.com
Yafei Yin, MD
About this study
Official title: Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study
The morphologic change of microvessels has the clinical value to distinguish cancerous from non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal blood flow in GIM.
Read the detailed description
Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. Before the endomicroscopic examination, 20,000 U α-chymotrypsin and 80 mg dimethylpolysiloxane were given orally to remove gastric mucus. All patients were given intravenous injections of 1 ml of 2% fluorescein sodium (Baiyunshan Mingxing Pharmaceutical, Guangzhou, China) as an allergy test before procedures were carried out. Conscious sedation was achieved for each patient by using propofol and fentanyl, and vital signs were monitored during the entire procedure. After successful intubation of the endoscope into the gastric antrum, 1 mL fluorescein sodium solution was applied intravenously as a contrast dye. The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum. Finally, targeted biopsy of the examined site was performed.
- Conditions
- Flow Determination
- Being tested
- CLE
- Keywords
- Probe-based confocal laser endomicroscopy, chronic atrophic antral gastritis, microcirculatory dynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEDevice
The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum.
| Study group | Role | What they receive |
|---|---|---|
| gastric intestinal metaplasia | Those fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included. Receives: Device: CLE | |
| normal gastric | diagnosed during routine colonoscopy procedures. Receives: Device: CLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood flow state
Flow determination cannot yet be done automatically. It requires a semi-quantitative analysis involving subjective assessment. Assessment of flow determination was based on the previously published consensus criteria, in which flow was classified into seven grades.
Flow was categorized as: "linear flow" (fast and continuous flow, like plastic tape without grainy), "linear particle flow"(fast and continuous flow, like ribbon with mild grainy), "particle linear flow"(fast and continuous flow, like cotton tape with obvious grainy), "particle flow"(sluggish flow like mud-sand flow), "slowly particle flow"(slow but continuous), "particle of pendulum flow"(swinging silt flow) and "stagnate"(no flow).
Measured: 5 months
microvascular area in μm2
We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case.
Measured: 5 months
microvascular diameter in μm
We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case.
Measured: 5 months
Secondary outcomes (1)
vascular morphology
It included normal or tortuous and dilation.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flow DeterminationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595151
- Sponsor's protocol ID
- 2015SDU-QILU-G001
- Status last verified
- Sep 2015
- First submitted
- 29 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02595151
- Acronym / sponsor ID
- 2015SDU-QILU-G001
- Conditions
- Flow Determination
- Keywords
- Probe-based confocal laser endomicroscopy, chronic atrophic antral gastritis, microcirculatory dynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 3 Nov 2015 (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.
The morphologic change of microvessels has the clinical value to distinguish cancerous from non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal blood flow in GIM.
Detailed description
Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. Before the endomicroscopic examination, 20,000 U α-chymotrypsin and 80 mg dimethylpolysiloxane were given orally to remove gastric mucus. All patients were given intravenous injections of 1 ml of 2% fluorescein sodium (Baiyunshan Mingxing Pharmaceutical, Guangzhou, China) as an allergy test before procedures were carried out. Conscious sedation was achieved for each patient by using propofol and fentanyl, and vital signs were monitored during the entire procedure. After successful intubation of the endoscope into the gastric antrum, 1 mL fluorescein sodium solution was applied intravenously as a contrast dye. The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum. Finally, targeted biopsy of the examined site was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric intestinal metaplasia | – | Device: CLEThose fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included. |
| normal gastric | – | Device: CLEdiagnosed during routine colonoscopy procedures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. 94 patients were eligible for analysis (50 males and 44 females; average age 53 years, range 22-80 years).
Key inclusion criteria (2 listed)
- Male or Female aged 18-80 ;
- Those fulfilling the criteria of GIM according to the study by Yuting Guo et al were included.
Key exclusion criteria (4 listed)
- patients younger than 18 years or older than 80 years;
- finding of acute GI bleeding, gastrectomy or known upper gastrointestinal cancer;
- unwillingness to participate in this study;
- contraindications to CLE, such as fluorescein allergy, hepatic or renal dysfunction, jaundice, pregnancy and/or breast feeding, coagulopathy.
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 |
|---|---|---|
| CLEThe CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum. | Device | gastric intestinal metaplasia, normal gastric |
Primary outcome
blood flow state
Time frame: 5 months
Flow determination cannot yet be done automatically. It requires a semi-quantitative analysis involving subjective assessment. Assessment of flow determination was based on the previously published consensus criteria, in which flow was classified into seven grades. Flow was categorized as: "linear flow" (fast and continuous flow, like plastic tape without grainy), "linear particle flow"(fast and continuous flow, like ribbon with mild grainy), "particle linear flow"(fast and continuous flow, like cotton tape with obvious grainy), "particle flow"(sluggish flow like mud-sand flow), "slowly particle flow"(slow but continuous), "particle of pendulum flow"(swinging silt flow) and "stagnate"(no flow).
microvascular area in μm2
Time frame: 5 months
We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case.
microvascular diameter in μm
Time frame: 5 months
We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case.
1 secondary outcome
vascular morphology
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Xiuli Zuo, 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 Flow Determination, 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 4 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 3 Nov 2015. 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 Xiuli Zuo, PhD (15588818685 ext. 0531-88369277, xiulizuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood flow state (time frame: 5 months). The study lists 3 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 3 Nov 2015.