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

Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02515721

Acronym

PCLE

Enrollment

242

Registered

2015-08-05

Start date

2014-07-31

Completion date

Unknown

Last updated

2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Yield of Gastric Neoplasia

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.

Interventions

DEVICEpCLE-TB

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.

DEVICEvirtual chromoendoscopy-TB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer	12 months

Secondary

Measure	Time frame
the biopsy number needed for diagnosis	12 months

Countries

China

Contacts

Primary ContactLi Yanqing, PhD, MD

liyanqing@sdu.edu.cn053182169385

Backup ContactLi Zhen, PhD, MD

lizhenh@hotmail.com18560086106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026