Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01688687

Acronym

pCLE

Enrollment

Registered

2012-09-20

Start date

2012-02-29

Completion date

Unknown

Last updated

2012-09-20

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

Conditions

Early Gastric Cancer, Gastric Dysplasia

Brief summary

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis, and off-line interobserver agreement.

Interventions

PROCEDUREEndoscopic submucosal dissection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

Exclusion criteria

* Patients with uncorrectable coagulopathy, * liver cirrhosis, * acute gastrointestinal bleeding, * pregnancy, * breast feeding, * documented allergy to fluorescein, * patients with lesions that were deemed unsuitable for endoscopic resection, and * patients without documented conventional biopsy results.

Design outcomes

Primary

Measure	Time frame	Description
The accuracy of pCLE compared to conventional forceps biopsy	in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.	The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference

Secondary

Measure	Time frame
Comparison of real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis.	1-3 months after endoscopic resection and final histopathological analysis
Off-line pCLE interobserver agreement	1-3 months after endoscopic resection and final histopathological analysis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026