- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534818
Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
Conventional Fluorescein Sodium Dosage o.1ml/kg Compared With a Lower Fluorescein Sodium Dosage o.02ml/kg for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.
This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yanqing Li, PhD. MD
- Phone Number: 82169508 18678827666
- Email: qiluliyanqing@gmail.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Department of Gastroenterology, Qilu Hospital, Shandong University
-
Contact:
- Yanqing Li, MD, PhD
- Phone Number: 82169508 86-531-82169236
- Email: liyanqing@sdu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Exclusion Criteria:
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
|
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
|
Active Comparator: Group 2
conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia
|
fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis
Time Frame: six months
|
six months
|
Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis
Time Frame: six months
|
six months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yanqing Li, PhD. MD, Department of Gastroenterology, Qilu Hospital, Shandong University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015SDU-QILU-G09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Intestinal Metaplasia
-
Shandong UniversityUnknownGastric Intestinal Metaplasia | Confocal Laser Endomicroscopy | Biopsy | Operative Link on Gastric Intestinal MetaplasiaChina
-
Xijing Hospital of Digestive DiseasesCompleted
-
Shandong UniversityUnknownGastric Intestinal MetaplasiaChina
-
Shandong UniversityUnknownGastric Intestinal MetaplasiaChina
-
Shandong UniversityUnknownGastric Intestinal MetaplasiaChina
-
Shandong UniversityCompletedGastric Intestinal MetaplasiaChina
-
King Chulalongkorn Memorial HospitalCompletedGastric Intestinal MetaplasiaThailand
-
King Chulalongkorn Memorial HospitalUnknownGastric Intestinal MetaplasiaThailand
-
Shandong UniversityNot yet recruitingHelicobacter Pylori | the Operative Link on Gastric Intestinal Metaplasia | Operative Link on Gastric Intestinal AssessmentChina
-
The University of Hong KongCompletedIntestinal Metaplasia | Gastric DysplasiaHong Kong
Clinical Trials on lower fluorescein sodium dosage 0.02ml/kg
-
Shandong UniversityUnknownImage Quality | Skin DiscolorationChina
-
Ain Shams UniversityCompleted
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States