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Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

Primary Purpose

Early Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

LCI+white light

About this trial

This is an interventional diagnostic trial for Early Gastric Cancer focused on measuring Linked-color imaging, Detection

Eligibility Criteria

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

Inclusion Criteria:

High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer;
First degree relatives of patients with gastric cancer;
There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
The informed consent has been signed.

Exclusion Criteria:

The TNM classification of cancer is consistent with those diagnosed by T2 above.
Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy.
There were contraindications for gastroscopy.
A patient without self judgement;
Those who did not sign informed consent.
Previous gastroscopy has found suspicious lesions requiring careful examination.

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

LCI+white light

White light

Arm Description

Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Using white light only.

Outcomes

Primary Outcome Measures

Detection rate of gastric neoplastic lesion

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Secondary Outcome Measures

Specificity of detecting gastric neoplastic lesion

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Sensitivity of detecting gastric neoplastic lesion

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Full Information

NCT ID

NCT03661671

First Posted

September 3, 2018

Last Updated

September 5, 2018

Sponsor

Changhai Hospital

Collaborators

Shanxi Province Cancer Hospital, First People's Hospital of Hangzhou, 307 Hospital of PLA, Jiangsu Province Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Xiamen University, Chongqing University Cancer Hospital, Guilin Medical University, China, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiangya Hospital of Central South University, Wuhan University, Xi'an Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03661671

Brief Title

Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

Official Title

Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

January 1, 2019 (Anticipated)

Study Completion Date

January 1, 2019 (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 purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Detailed Description

The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new 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

Early Gastric Cancer

Keywords

Linked-color imaging, Detection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LCI+white light

Arm Type

Experimental

Arm Description

Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Arm Title

White light

Arm Type

No Intervention

Arm Description

Using white light only.

Intervention Type

Diagnostic Test

Intervention Name(s)

LCI+white light

Intervention Description

Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Primary Outcome Measure Information:

Title

Detection rate of gastric neoplastic lesion

Description

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Time Frame

immediately following the procedure

Secondary Outcome Measure Information:

Title

Specificity of detecting gastric neoplastic lesion

Description

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Time Frame

immediately following the procedure

Title

Sensitivity of detecting gastric neoplastic lesion

Description

Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Time Frame

immediately following the 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: High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer; First degree relatives of patients with gastric cancer; There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.). Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR). The informed consent has been signed. Exclusion Criteria: The TNM classification of cancer is consistent with those diagnosed by T2 above. Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy. There were contraindications for gastroscopy. A patient without self judgement; Those who did not sign informed consent. Previous gastroscopy has found suspicious lesions requiring careful examination.

Central Contact Person:

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

Dong Wang, M.D

Phone

8613816758802

dongwang0901@sina.com

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

Jie Gao, M.D

Phone

8613761272863

jesseegao@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoshen 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

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Wang, MD

Phone

008613816758802

dongwang0901@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26560036

Citation

Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.

Results Reference

result

PubMed Identifier

26867550

Citation

Okada M, Sakamoto H, Takezawa T, Hayashi Y, Sunada K, Lefor AK, Yamamoto H. Laterally Spreading Tumor of the Rectum Delineated with Linked Color Imaging Technology. Clin Endosc. 2016 Mar;49(2):207-8. doi: 10.5946/ce.2015.077. Epub 2016 Feb 12. No abstract available.

Results Reference

result

PubMed Identifier

27641243

Citation

Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.

Results Reference

result

Learn more about this trial

Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

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