Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Completed

• Conditions: Gastric Dysplasia; Early Gastric Cancer
• Interventions: Procedure: Endoscopic submucosal dissection

• Registration Number: NCT01688687
• Lead Sponsor: Soonchunhyang University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-20
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Superficial gastric neoplasia	Endoscopic submucosal dissection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Soonchunhyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of