Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Soon Chun Hyang University

Status: Completed

Conditions: Early Gastric Cancer; Gastric Dysplasia

Treatments: Procedure: Endoscopic submucosal dissection

Study type: Observational

Funder types: Other

Identifiers

NCT01688687

MD-2012-01

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

63 participants in 1 patient group

Superficial gastric neoplasia

Description:

Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.

Treatment:

Procedure: Endoscopic submucosal dissection