Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study

February 8, 2019 updated by: Yonsei University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  1. Adults over 19 years of age
  2. Patients who are diagnosed gastric adenoma or early gastric cancer by esophagogastroduodenoscopy and are planning endoscopic resection or surgical resection for cure.
  3. Patients who understand that they have the right to sign the consent form prior to the initiation of treatment and to withdraw from the clinical trial without penalty at any time.

Exclusion Criteria:

  1. Failed to obtain informed consent of the patient or guardian.
  2. Anyone deemed inappropriate by the researchers or the primary care physician in clinical studies.
  3. Women who are pregnant and possibly pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUS
group using conventional WLE and EUS
ME-NBI
group using WLE and ME-NBI.
Device: magnifying endoscopy with narrow band imaging (ME-NBI)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy in predicting the invasion depth of EGC.
Time Frame: Within 1 month after lesion resection
To compare the accuracy of EUS and ME-NBI in predicting the invasion depth of EGC using final pathology result.
Within 1 month after lesion resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The NBI findings that affect the accuracy for predicting of depth.
Time Frame: Within 1 month after lesion resection

The characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma such as microvessels, pits, histological patterns.

For example) ME-NBI classification Type A : clear regular surface patterns and microvascular architecture. Type B : obscure irregular surface patterns or microvascular architecture. Type C :no surface pattern and sparse microvessels or with avascular areas. Finally, to evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.
Within 1 month after lesion resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 3, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-0220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information related to this study will be used purely for research purposes and all data will be encrypted and strictly kept confidential and protected. In order to protect the personal information of the patient, information about the patient's identity and information about the patient will be managed as independent data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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