Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02930616
Other study ID # 2016SDU-QILU-17
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received October 10, 2016
Last updated October 11, 2016
Start date October 2016
Est. completion date June 2017

Study information

Verified date October 2016
Source Shandong University
Contact Li Yanqing, MD, PhD
Phone 86-531-82169236
Email liyanqing@sdu.edu.cn
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial Summary

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Patients aged 40 years or older with Helicobacter pylori infection;

- Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;

- Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;

- Pregnancy or breastfeeding;

- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Patients in Group 1 will receive pCLE at first and WLE 2 months later

patients in Group 2 will receive WLE at first and pCLE 2 months later.


Locations

Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. 9 months No
Primary the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE. 9 months No
Secondary the overall detection rate of GIM by pCLE. 9 months No
Secondary the overall detection rate of GIM by WLE. 9 months No
See also
  Status Clinical Trial Phase
Recruiting NCT02428426 - Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue. N/A
Completed NCT02846688 - Gene Expression Profiling in Human Gastric Intestinal Metaplasia Mucosa and Duodenal Mucosa N/A
Unknown status NCT01491724 - The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia (GIM) N/A
Active, not recruiting NCT02794428 - Chemoprevention of Gastric Carcinogenesis Phase 2
Completed NCT03672708 - Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia N/A
Recruiting NCT01490541 - The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population N/A
Recruiting NCT05657080 - Cytosponge for Gastric Intestinal Metaplasia
Recruiting NCT04869618 - Validation of an Artificial Intelligence System Based on Raman Spectroscopy for Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer N/A
Recruiting NCT02516735 - I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia N/A
Completed NCT05345314 - Endoscopic Grading of Intestinal Metaplasia
Recruiting NCT02534818 - Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia Phase 4
Recruiting NCT01646528 - The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy N/A
Recruiting NCT03250091 - Surveillance of Patients With Precancerous Lesions of the Stomach
Not yet recruiting NCT04843397 - Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study
Completed NCT04348266 - RFA for GIM Treatment N/A
Recruiting NCT02725034 - Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement N/A
Completed NCT01945177 - RCT: WLE vs. NBI in Upper Gastrointestinal Endoscopy N/A
Not yet recruiting NCT01642797 - Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma N/A
Completed NCT01384201 - Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia N/A
Recruiting NCT05447221 - Automatic Evaluation of the Severity of Gastric Intestinal Metaplasia With Pathology Artificial Intelligence Diagnosis System