Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-24 @ 3:43 AM
Study NCT ID:
NCT02595151
Status:
UNKNOWN
Last Update Posted:
2015-11-03
First Post:
2015-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: