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PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma (PCLE)

Primary Purpose

Diagnostic Yield of Gastric Neoplasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pCLE-TB
virtual chromoendoscopy-TB
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnostic Yield of Gastric Neoplasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged between 18 and 80;
  • patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
  • agree to give written informed consent.

Exclusion Criteria:

  • Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
  • Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
  • Inability to provide informed consent

Sites / Locations

  • Endoscopic unit of Qilu Hospital Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

pCLE-TB

Virtual Chromoendoscopy -SB

Arm Description

Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.

Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.

Outcomes

Primary Outcome Measures

the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer

Secondary Outcome Measures

the biopsy number needed for diagnosis

Full Information

First Posted
August 3, 2015
Last Updated
August 3, 2015
Sponsor
Shandong University
Collaborators
Wuhan Union Hospital, China, Tongji Hospital, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02515721
Brief Title
PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Acronym
PCLE
Official Title
Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Wuhan Union Hospital, China, Tongji Hospital, Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Yield of Gastric Neoplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pCLE-TB
Arm Type
Experimental
Arm Description
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
Arm Title
Virtual Chromoendoscopy -SB
Arm Type
Experimental
Arm Description
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
Intervention Type
Device
Intervention Name(s)
pCLE-TB
Other Intervention Name(s)
probe-based confocal laser endomicroscopy with targeted biopsies
Intervention Description
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
Intervention Type
Device
Intervention Name(s)
virtual chromoendoscopy-TB
Other Intervention Name(s)
virtual chromoendoscopy with targeted biopsies
Intervention Description
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
Primary Outcome Measure Information:
Title
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the biopsy number needed for diagnosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 18 and 80; patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia; agree to give written informed consent. Exclusion Criteria: Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia; Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yanqing, PhD, MD
Phone
053182169385
Email
liyanqing@sdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhen, PhD, MD
Phone
18560086106
Email
lizhenh@hotmail.com
Facility Information:
Facility Name
Endoscopic unit of Qilu Hospital Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yanqing, PhD, MD
Phone
053182169385
Email
liyanqing@sdu.edu.cn
First Name & Middle Initial & Last Name & Degree
Li Zhen, PhD, MD
Phone
18560086106
Email
lizhenh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zuo Xiuli, PhD, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28753702
Citation
Zuo XL, Li Z, Li CQ, Zheng YY, Xu LD, Chen J, Lin R, Song J, Yu CH, Yue M, Zhou Q, Liu ZY, Li YQ. Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial. Endoscopy. 2017 Nov;49(11):1033-1042. doi: 10.1055/s-0043-115382. Epub 2017 Jul 28.
Results Reference
derived

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PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

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