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

NCT02595151 | Unknown DMC

• 1 other identifier: 2015SDU-QILU-G001
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Flow Determination

Keywords

Probe-based confocal laser endomicroscopy; chronic atrophic antral gastritis; microcirculatory dynamics

Outcome Measures

Primary Outcomes (3)

• 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.

  5 months

Secondary Outcomes (1)

• vascular morphology

  5 months

Study Arms (2)

gastric intestinal metaplasia

Those fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included.

Device: CLE

normal gastric

diagnosed during routine colonoscopy procedures.

Device: CLE

Interventions

CLE DEVICE

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.

gastric intestinal metaplasia; normal gastric

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

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.

Study Officials

• Xiuli Zuo, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD

CONTACT

15588818685; xiulizuo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 3, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-09

Locations

CN (1)