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

Shandong University

Status: Unknown

Conditions: Flow Determination

Treatments: Device: CLE

Study type: Observational

Funder types: Other

Identifiers

NCT02595151

2015SDU-QILU-G001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

94 participants in 2 patient groups

gastric intestinal metaplasia

Description:

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

Treatment:

Device: CLE

normal gastric

Description:

diagnosed during routine colonoscopy procedures.

Treatment:

Device: CLE