Application of OE in Diagnosis of EGC

January 21, 2021 updated by: Zhaoshen Li, Changhai Hospital

Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study

The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed. Optical Enhancement (OE) mode is an endoscopic mode that uses the principle of grating for electronic staining, which provides a clear picture of the submucosal and superficial mucosal vascular structures. The OE1 mode provides enhanced images of the gastric Gland tube and blood vessels, as well as magnification. The OE2 mode is used to identify small chromatic aberrations and to visualize superficial structures in the gastric mucosa. So we designed this randomized controlled trial to discuss effectiveness of OE in the diagnosis of early gastric cancer and we hope to find an effective method to improve the detection rate of early gastric cancer in China.

Study Type

Interventional

Enrollment (Anticipated)

2454

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Department of Gastroenterology, Changhai Hospital, Second Military Medical University

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

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Meet item 1or 2 + any items of 3-7

  1. Male ≥ 40 years old, female ≥ 50 years old.
  2. More than one year since the last gastroscopy.
  3. Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai).
  4. Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
  5. First-degree relatives of patients with a family history of gastric cancer.
  6. Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.)
  7. Positive serum gastric function tests (GastroPanel) include: H. pylori (H.P) antibody （+）, Fasting pepsinogen I and II ratio (PG I/PGII) <3.89, gastrin 17 (G-17) >1.50 pmol/L.

Exclusion Criteria:

  1. Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
  2. Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
  3. Patients on anticoagulants that cannot be biopsied.
  4. Patients who have undergone gastrectomy.
  5. Patients who have taken PPIs or H2 receptor antagonist within two weeks.
  6. Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women.
  7. Patients who did not signed the consent form.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OE+white light
Using white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus.
Diagnostic test: OE+white light
Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus
NO_INTERVENTION: White light
Using White light to observe from esophagus to duodenum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of gastric neoplastic lesion
Time Frame: procedure
Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma
procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Specificity of detecting gastric neoplastic lesion
Time Frame: procedure
procedure
Sensitivity of detecting gastric neoplastic lesion
Time Frame: procedure
procedure

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Collaborators

First People's Hospital of Hangzhou
Tongji Hospital
Qilu Hospital of Shandong University
Peking University Cancer Hospital & Institute
Shengjing Hospital
Nanjing First Hospital, Nanjing Medical University
Tang-Du Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
First Affiliated Hospital of Guangxi Medical University
Sino-Japanese Friendship Hospital of Jilin University
Zhengzhou Central Hospital
The First People's Hospital of Guangzhou

Investigators

  • Principal Investigator: Zhao shen Li, M.D., Department of Gastroenterology, Changhai Hospital, Second Military Medical 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 (ACTUAL)

May 10, 2019

Primary Completion (ANTICIPATED)

March 10, 2021

Study Completion (ANTICIPATED)

May 10, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OE2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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