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Status unknownNCT04720521Updated Jan 22, 2021

Application of OE in Diagnosis of EGC

An interventional study of OE+white light in High Risk Population of Gastric Cancer, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled May 2019, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
2,454
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • High Risk Population of Gastric Cancer

Browse trials for

Keywords

  • early gastric cancer
  • Optical Enhancement
  • Detection Rate
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 2,454 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,454 participants (estimated)

Study arms

  • 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

  • No intervention
    White light

    Using White light to observe from esophagus to duodenum.

Interventions

  • Diagnostic testOE+white light

    Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus

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What researchers measure

Primary outcomes

  1. Detection rate of gastric neoplastic lesion

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

    Time frame: procedure

Secondary outcomes

  1. Specificity of detecting gastric neoplastic lesion

    Time frame: procedure

  2. Sensitivity of detecting gastric neoplastic lesion

    Time frame: procedure

07

Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, Changhai Hospital, Second Military Medical University
    Shanghai, Shanghai 200433, China
    Recruiting
08

References and documents

Publications

  • Gomez JM, Wang AY. Gastric intestinal metaplasia and early gastric cancer in the west: a changing paradigm. Gastroenterol Hepatol (N Y). 2014 Jun;10(6):369-78. PubMed 25013389 ↗
  • Nagao M, Nishikawa J, Ogawa R, Sasaki S, Nakamura M, Nishimura J, Goto A, Hashimoto S, Okamoto T, Suenaga M, Hamamoto Y, Sakaida I. Evaluation of the Diagnostic Ability of Optical Enhancement System in Early Gastric Cancer Demarcation. Gastroenterol Res Pract. 2016;2016:2439621. doi: 10.1155/2016/2439621. Epub 2016 Sep 28. PubMed 27774101 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04720521
Lead sponsor
Changhai Hospital
Collaborators
Qilu Hospital of Shandong University, Shengjing Hospital, Zhengzhou Central Hospital, 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
Responsible party
Zhaoshen Li (Director of Gastroenterology Dept, Changhai Hospital) — Principal investigator
First posted
Jan 22, 2021
Start date
May 10, 2019
Primary completion
Mar 10, 2021 (estimated)
Completion
May 10, 2021 (estimated)
Last update
Jan 22, 2021

Study contacts

Liang hao Hu, M.D.
Contact
lianghao-hu@hotmail.com
8613817593520
Di Zhang, M.D.
Contact
hugh_zd@sina.com
8613162039421
Zhao shen Li, M.D.
principal investigator · Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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