Sponsor study identifier
observational
94
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 29, 2015
Actual (reported)November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 3, 2015
Actual (reported)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).
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.
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.
vascular morphology
5 months
Those fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included.
diagnosed during routine colonoscopy procedures.
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.
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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).
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
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.
Xiuli Zuo, PhD
Qilu Hospital of Shandong University
First Submitted
October 29, 2015
First Posted
November 3, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
5 months
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 3, 2015
Record last verified: 2015-09
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