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A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy


N/A
40 Years
85 Years
Not Enrolling
Both
Stomach Neoplasms

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Trial Information

A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy


Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible
for inclusion. WLE without magnification was performed first in eligible patients. Based on
an assessment of the shape (such as flat, depressed or elevated) and color (pale or
reddened), small focal gastric lesions were identified and included for evaluation by
experienced endoscopists. When such a lesion was detected during non-magnifying observation
with WLE, the mode was then changed to ME-NBI for observation of microvascular pattern and
ME-AIM for observation of microsurface pattern subsequently. All endoscopic images of the
whole procedure were recorded in digital filing system for later evaluation. To avoid
possible selection bias and to maintain the quality of the study, all images of each
endoscopic modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one
slide and displayed independently of the images of other endoscopic modality, were evaluated
by 4 skilled endoscopists, who were not access to the clinical and pathological data. The
general consensus was established for an assessment of each lesion. Two forceps biopsy
specimens were taken from each lesion and pathological diagnosis were used as the criterion
standard for cancer diagnosis.


Inclusion Criteria:



- Patients, in which small focal gastric lesions were identified with conventional WLE,
were enrolled in this study. Before being enrolled, all patients provided written
informed consent.

Exclusion Criteria:

- Patients who cannot undergo gastroscopies due to unsuitable conditions

- Referred patients with a history of having being diagnosed as gastric cancer

- Patients with a personal history of gastric surgery

- Patients who cannot provide informed consent

- Patients with advanced gastric cancer

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM)

Outcome Description:

Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.

Outcome Time Frame:

1 week

Safety Issue:

No

Principal Investigator

Xinghua Lu, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking Union Medical College Hospital

Authority:

China: Ministry of Health

Study ID:

LXH-EGC-1

NCT ID:

NCT01617876

Start Date:

March 2010

Completion Date:

March 2012

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • early gastric cancer
  • magnifying endoscopy
  • narrow band imaging
  • acetic acid
  • indigocarmine
  • Neoplasms
  • Stomach Neoplasms

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