Early Gastric Cancer Clinical Trial
Official title:
Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study
The treatment of early gastric cancer can be divided into endoscopic resection and surgery,
and the precise staging of early gastric cancer is very important to prevent unnecessary
surgery or additional surgery after the procedure. The possibility of endoscopic resection is
determined by the risk of lymph node metastasis. The risk factors of lymph node metastasis of
early gastric cancer are lesion size, presence of ulceration, histologic differentiation, and
depth of invasion. In contrast to other factors, the factor of invasion depth is relatively
difficult to predict by using the conventional white light endoscopy (WLE). Therefore, the
endoscopic ultrasonography (EUS) has been tried to use for prediction of the invasion depth.
However, many studies reported that the accuracy of endoscopic ultrasonography for predicting
the depth of invasion was varied.
A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with
the spectral band width narrowed by optical filters, was developed to enhance visualization
of mucosal surface structure and vascular architecture. There were some reports that the
magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic
differentiation, depth of invasion and lesion margin than WLE.
In this study, we divide the patients with suspected early gastric cancer (EGC) into the two
groups as group using conventional WLE and EUS and group using WLE and ME-NBI, and try to
compare the accuracy of EUS and ME-NBI for predicting the invasion depth of EGC. We also try
to analyze the factors that affect the accuracy for predicting of depth such as
characteristics of cancer lesion and histologic differentiation of cancer in each group. In
addition, we try to analyze the characteristic imaging findings of ME-NBI for early gastric
cancer and gastric adenoma and evaluate the efficacy of ME-NBI for early gastric cancer and
gastric adenoma diagnosis.
The subjects is divided into early gastric cancer patients and gastric adenoma patients
according to histologic biopsy result and white light endoscopic findings. Study 1 applies
for early gastric cancer patients, Study 2 applies for gastric adenoma patients.
A) Study 1 The NBI group performs ME-NBI first before EUS. The endoscopist evaluates NBI
findings such as the invasion depth and describes ME-NBI impression. And then, EUS is
performed likewise. The final treatment plan is determined by the EUS result, so group
assignment does not affect the final treatment plan.
The EUS group performs EUS first before NBI. The endoscopist evaluates EUS findings such as
the invasion depth and describes EUS impression. And then, ME-NBI is performed likewise. The
final treatment plan is determined by the EUS result, so group assignment does not affect the
final treatment plan.
According to clinical stage of early gastric cancer, endoscopic resection is performed in
case of endoscopic resection indication or beyond indication but case of having the risk of
surgery according to patient status. The surgical resection is performed if the patient wants
surgery or does not meet the indications of endoscopic resection.
The pathologist performs a histological evaluation of the resected gastric cancer lesion,
including an invasive depth.
B) Study 2 First, the endoscopist performs WLE and describes WLE findings and impression such
as location, size, and gross morphology of lesion. The same examiner performs ME-NBI and
describes ME-NBI findings and impression such as mucosal pattern, predicted degree of
dysplasia.
Endoscopic resection or surgical resection is performed according to the results of
histologic result of gastric adenoma.
The pathologist performs a histological evaluation of the resected dysplastic lesion.
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