Clincosm LogoSign in Get a demo

Application of OE in Diagnosis of EGC

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04720521
Collaborator
Qilu Hospital of Shandong University (Other), Shengjing Hospital (Other), Zhengzhou Central Hospital of Zhengzhou University (Other), Shanghai Tongji Hospital, Tongji University School of Medicine (Other), Tang-Du Hospital (Other), Sino-Japanese Friendship Hospital of Jilin University (Other), First People's Hospital of Hangzhou (Other), Nanjing First Hospital, Nanjing Medical University (Other), Peking University Cancer Hospital & Institute (Other), The First People's Hospital of Guangzhou (Other), First Affiliated Hospital of Guangxi Medical University (Other), Tongji Hospital (Other)
2,454
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
102.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: OE+white light
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2454 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study
Actual Study Start Date :
May 10, 2019
Anticipated Primary Completion Date :
Mar 10, 2021
Anticipated Study Completion Date :
May 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Detection rate of gastric neoplastic lesion [procedure]

    Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma

Secondary Outcome Measures

  1. Specificity of detecting gastric neoplastic lesion [procedure]

  2. Sensitivity of detecting gastric neoplastic lesion [procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastroenterology, Changhai Hospital, Second Military Medical University Shanghai Shanghai China 200433

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT04720521
Other Study ID Numbers:
  • OE2021
First Posted:
Jan 22, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
early gastric cancer
Optical Enhancement
Detection Rate
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Jan 22, 2021