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Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

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ClinicalTrials.gov Identifier: NCT02595151
Recruitment Status : Unknown
Verified September 2015 by Xiuli Zuo, Shandong University.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief 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 possible mechanisms associated with gastric mucosal blood flow in GIM.

Condition or disease Intervention/treatment
Flow Determination Device: CLE

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.

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Study Type : Observational
Estimated Enrollment : 94 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study
Study Start Date : March 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Group/Cohort Intervention/treatment
gastric intestinal metaplasia
Those fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included.
Device: CLE
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.

normal gastric
diagnosed during routine colonoscopy procedures.
Device: CLE
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.




Primary Outcome Measures :
  1. 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).


  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. vascular morphology [ Time Frame: 5 months ]
    It included normal or tortuous and dilation.


Biospecimen Retention:   Samples Without DNA
Targeted fresh biopsy samples from each examined site were fixed in 10% pH neutral formalin, and embedded in paraffin. Slides of 4-um sections were deparaffinized and hydrated. After antigen retrieval and blocking procedures, Immunology and Histology Chemistry (IHC) staining for CD34 was performed by mouse anti-CD34 monoclonal antibody (ZM-0046, ZSGB-BIO, Beijjing, China) as per the manufacturers' instructions.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  1. Male or Female aged 18-80 ;
  2. Those fulfilling the criteria of GIM according to the study by Yuting Guo et al were included.

Exclusion Criteria:

  1. patients younger than 18 years or older than 80 years;
  2. finding of acute GI bleeding, gastrectomy or known upper gastrointestinal cancer;
  3. unwillingness to participate in this study;
  4. contraindications to CLE, such as fluorescein allergy, hepatic or renal dysfunction, jaundice, pregnancy and/or breast feeding, coagulopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595151


Contacts
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Contact: Xiuli Zuo, PhD 15588818685 ext 0531-88369277 xiulizuo@gmail.com

Locations
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China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xiuli Zuo, PhD    15588818685 ext 15588818685    xiulizuo@gmail.com   
Sub-Investigator: Yafei Yin, MD         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, PhD Qilu Hospital of Shandong University
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Responsible Party: Xiuli Zuo, director of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02595151    
Other Study ID Numbers: 2015SDU-QILU-G001
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: September 2015
Keywords provided by Xiuli Zuo, Shandong University:
Probe-based confocal laser endomicroscopy
chronic atrophic antral gastritis
microcirculatory dynamics
Additional relevant MeSH terms:
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Metaplasia
Pathologic Processes