Clinical trial NCT04720521: Application of OE in Diagnosis of EGC
Official title: Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Risk Population of Gastric Cancer
Keywords: early gastric cancer
Optical Enhancement
Detection Rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Shengjing Hospital
name: Zhengzhou Central Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Tang-Du Hospital
name: Sino-Japanese Friendship Hospital of Jilin University
name: First People's Hospital of Hangzhou
name: Nanjing First Hospital, Nanjing Medical University
name: Peking University Cancer Hospital & Institute
name: The First People's Hospital of Guangzhou
name: First Affiliated Hospital of Guangxi Medical University
name: Tongji Hospital
First posted: 2021-01-22
Enrollment: 2454
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of gastric neoplastic lesion
timeFrame: procedure
Secondary outcomes:
measure: Specificity of detecting gastric neoplastic lesion
timeFrame: procedure
measure: Sensitivity of detecting gastric neoplastic lesion
timeFrame: procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
name: Zhao shen Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Pract. 2016;2016:2439621. doi: 10.1155/2016/2439621. Epub 2016 Sep 28.