Application of OE in Diagnosis of EGC
Application of OpticalEnhancement Endoscopy（OE） in Diagnosis of Early Gastric Cancer: a Multicenter, Prospective, Randomized Controlled Study
1 other identifier
interventional
2,454
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2021
CompletedJanuary 22, 2021
January 1, 2021
1.8 years
January 20, 2021
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection rate of gastric neoplastic lesion
Include early gastric cancer, high-grade neoplasia, low-grade neoplasia and adenoma
procedure
Secondary Outcomes (2)
Specificity of detecting gastric neoplastic lesion
procedure
Sensitivity of detecting gastric neoplastic lesion
procedure
Study Arms (2)
OE+white light
EXPERIMENTALUsing white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus.
White light
NO INTERVENTIONUsing White light to observe from esophagus to duodenum.
Interventions
Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus
Eligibility Criteria
You may qualify if:
- Meet item 1or 2 + any items of 3-7
- Male ≥ 40 years old, female ≥ 50 years old.
- More than one year since the last gastroscopy.
- 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).
- Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
- First-degree relatives of patients with a family history of gastric cancer.
- Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.)
- 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.
You may not qualify if:
- Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
- Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
- Patients on anticoagulants that cannot be biopsied.
- Patients who have undergone gastrectomy.
- Patients who have taken PPIs or H2 receptor antagonist within two weeks.
- Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women.
- Patients who did not signed the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- Qilu Hospital of Shandong Universitycollaborator
- Shengjing Hospitalcollaborator
- Zhengzhou Central Hospitalcollaborator
- Shanghai Tongji Hospital, Tongji University School of Medicinecollaborator
- Tang-Du Hospitalcollaborator
- Sino-Japanese Friendship Hospital of Jilin Universitycollaborator
- First People's Hospital of Hangzhoucollaborator
- Nanjing First Hospital, Nanjing Medical Universitycollaborator
- Peking University Cancer Hospital & Institutecollaborator
- The First People's Hospital of Guangzhoucollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Tongji Hospitalcollaborator
Study Sites (1)
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433, China
Related 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.
PMID: 25013389RESULTNagao 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.
PMID: 27774101RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao shen Li, M.D.
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology Dept
Study Record Dates
First Submitted
January 20, 2021
First Posted
January 22, 2021
Study Start
May 10, 2019
Primary Completion
March 10, 2021
Study Completion
May 10, 2021
Last Updated
January 22, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share