Clinical trial NCT01688687: Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia
Official title: The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Gastric Cancer
Gastric Dysplasia
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients referred to a tertiary medical center for endoscopic resection of gastric superficial lesions.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy of pCLE compared to conventional forceps biopsy
timeFrame: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.
Secondary outcomes:
measure: Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.
timeFrame: 1-3 months after endoscopic resection and final histopathological analysis
measure: Off-line pCLE interobserver agreement
timeFrame: 1-3 months after endoscopic resection and final histopathological analysis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
Study officials:
References:
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.
citation: 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.
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: 10.1055/s-0031-1291589. Epub 2012 Mar 1.
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 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.
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. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.