Application of OE in Diagnosis of EGC

High Risk Population of Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720521
• Other study ID #: OE2021
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: May 10, 2021

Study information

• Verified date: January 2021
• Source: Changhai Hospital
• Contact: Liang hao Hu, M.D.
• Phone: 8613817593520
• Email: lianghao-hu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2454
• Est. completion date: May 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Risk Population of Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Gastroenterology, Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

Changhai Hospital

Beijing Cancer Hospital, First Affiliated Hospital of Guangxi Medical University, First People's Hospital of Hangzhou, Nanjing First Hospital, Nanjing Medical University, Qilu Hospital of Shandong University, Shanghai Tongji Hospital, Tongji University School of Medicine, Shengjing Hospital, Sino-Japanese Friendship Hospital of Jilin University, Tang-Du Hospital, The First People's Hospital of Guangzhou, Tongji Hospital, Tongji Medical College, Wuhan Huazhong University of Science and Technology, Zhengzhou Central Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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 P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of gastric neoplastic lesion	Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma	procedure
Secondary	Specificity of detecting gastric neoplastic lesion		procedure
Secondary	Sensitivity of detecting gastric neoplastic lesion		procedure