Clinical trial NCT02595151: Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
Official title: Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flow Determination
Keywords: Probe-based confocal laser endomicroscopy
chronic atrophic antral gastritis
microcirculatory dynamics
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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.

Primary outcomes:
measure: blood flow state
timeFrame: 5 months
measure: microvascular area in μm2
timeFrame: 5 months
measure: microvascular diameter in μm
timeFrame: 5 months
Secondary outcomes:
measure: vascular morphology
timeFrame: 5 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: PRINCIPAL_INVESTIGATOR
References: