Back to resultsA Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
Primary Purpose
Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Intestinal Metaplasia
Eligibility Criteria
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.
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1
goup 2
Arm Description
Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later
patients in Group 2 will receive WLE at first and pCLE 2 months later.
Outcomes
Primary Outcome Measures
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
Secondary Outcome Measures
the overall detection rate of GIM by pCLE.
the overall detection rate of GIM by WLE.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02930616
Brief Title
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy, Operative Link on Gastric Intestinal Metaplasia, Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later
Arm Title
goup 2
Arm Type
Active Comparator
Arm Description
patients in Group 2 will receive WLE at first and pCLE 2 months later.
Intervention Type
Device
Intervention Name(s)
Patients in Group 1 will receive pCLE at first and WLE 2 months later
Intervention Type
Device
Intervention Name(s)
patients in Group 2 will receive WLE at first and pCLE 2 months later.
Primary Outcome Measure Information:
Title
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
Time Frame
9 months
Title
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
the overall detection rate of GIM by pCLE.
Time Frame
9 months
Title
the overall detection rate of GIM by WLE.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yanqing, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yanqing, MD, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Phone
86-0531-82169236
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
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