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Application of OE in Diagnosis of EGC

Primary Purpose

High Risk Population of Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

OE+white light

About this trial

This is an interventional diagnostic trial for High Risk Population of Gastric Cancer focused on measuring early gastric cancer, Optical Enhancement, Detection Rate

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Gastroenterology, Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OE+white light

White light

Arm Description

Using white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus.

Using White light to observe from esophagus to duodenum.

Outcomes

Primary Outcome Measures

Detection rate of gastric neoplastic lesion

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

Secondary Outcome Measures

Specificity of detecting gastric neoplastic lesion

Sensitivity of detecting gastric neoplastic lesion

Full Information

NCT ID

NCT04720521

First Posted

January 20, 2021

Last Updated

January 21, 2021

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

1. Study Identification

Unique Protocol Identification Number

NCT04720521

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

March 10, 2021 (Anticipated)

Study Completion Date

May 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Risk Population of Gastric Cancer

Keywords

early gastric cancer, Optical Enhancement, Detection Rate

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2454 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OE+white light

Arm Type

Experimental

Arm Description

Using white light firstly to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus.

Arm Title

White light

Arm Type

No Intervention

Arm Description

Using White light to observe from esophagus to duodenum.

Intervention Type

Diagnostic Test

Intervention Name(s)

OE+white light

Intervention Description

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

Primary Outcome Measure Information:

Title

Detection rate of gastric neoplastic lesion

Description

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

Time Frame

procedure

Secondary Outcome Measure Information:

Title

Specificity of detecting gastric neoplastic lesion

Time Frame

procedure

Title

Sensitivity of detecting gastric neoplastic lesion

Time Frame

procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang hao Hu, M.D.

Phone

8613817593520

lianghao-hu@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Di Zhang, M.D.

Phone

8613162039421

hugh_zd@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhao shen Li, M.D.

Organizational Affiliation

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25013389

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.

Results Reference

result

PubMed Identifier

27774101

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.

Results Reference

result

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Application of OE in Diagnosis of EGC

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