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

NCT ID: NCT02595151

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Flow Determination

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

gastric intestinal metaplasia

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

CLE

Intervention Type: 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.

normal gastric

diagnosed during routine colonoscopy procedures.

CLE

Intervention Type: 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.

Interventions

CLE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

director of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Zuo, PhD

Role: CONTACT

xiulizuo@gmail.com

15588818685 ext. 0531-88369277

Facility Contacts

Xiuli Zuo, PhD

Role: primary

xiulizuo@gmail.com

15588818685 ext. 15588818685

Other Identifiers

2015SDU-QILU-G001

Identifier Type: -

Identifier Source: org_study_id