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Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

NCT ID: NCT01688687

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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Conditions

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Early Gastric Cancer Gastric Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Superficial gastric neoplasia

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.

Endoscopic submucosal dissection

Intervention Type PROCEDURE

Interventions

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Endoscopic submucosal dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gene Hyun Bok

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 21818734 (View on PubMed)

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 Endosc. 2011 Oct;74(4):772-80. doi: 10.1016/j.gie.2011.05.005. Epub 2011 Jul 29.

Reference Type RESULT
PMID: 21802680 (View on PubMed)

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: 10.1055/s-0031-1291589. Epub 2012 Mar 1.

Reference Type RESULT
PMID: 22382851 (View on PubMed)

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 metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

Reference Type RESULT
PMID: 22749368 (View on PubMed)

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. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.

Reference Type RESULT
PMID: 22459661 (View on PubMed)

Other Identifiers

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MD-2012-01

Identifier Type: -

Identifier Source: org_study_id