Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Early Gastric Cancer Clinical Trial

— pCLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688687
• Other study ID #: MD-2012-01
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: September 19, 2012
• Start date: February 2012

Study information

• Verified date: September 2012
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Gastric Cancer
• Gastric Dysplasia

Intervention

Procedure:
• Endoscopic submucosal dissection

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Jeon SR, Cho WY, Jin SY, Cheon YK, Choi SR, Cho JY. Optical biopsies by confocal endomicroscopy prevent additive endoscopic biopsies before endoscopic submucosal dissection in gastric epithelial neoplasias: a prospective, comparative study. Gastrointest E — View Citation

Kuiper T, Kiesslich R, Ponsioen C, Fockens P, Dekker E. The learning curve, accuracy, and interobserver agreement of endoscope-based confocal laser endomicroscopy for the differentiation of colorectal lesions. Gastrointest Endosc. 2012 Jun;75(6):1211-7. d — View Citation

Shahid MW, Buchner AM, Raimondo M, Woodward TA, Krishna M, Wallace MB. Accuracy of real-time vs. blinded offline diagnosis of neoplastic colorectal polyps using probe-based confocal laser endomicroscopy: a pilot study. Endoscopy. 2012 Apr;44(4):343-8. doi — View Citation

Wallace M, Lauwers GY, Chen Y, Dekker E, Fockens P, Sharma P, Meining A. Miami classification for probe-based confocal laser endomicroscopy. Endoscopy. 2011 Oct;43(10):882-91. doi: 10.1055/s-0030-1256632. Epub 2011 Aug 4. Review. — View Citation

Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of pCLE compared to conventional forceps biopsy	The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference	in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.	No
Secondary	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	No
Secondary	Off-line pCLE interobserver agreement		1-3 months after endoscopic resection and final histopathological analysis	No