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

NCT ID: NCT03661671

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-01-01

Brief Summary

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the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Detailed Description

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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.

Conditions

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Early Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LCI+white light

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

Group Type EXPERIMENTAL

LCI+white light

Intervention Type DIAGNOSTIC_TEST

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

White light

Using white light only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LCI+white light

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. First degree relatives of patients with gastric cancer;
3. There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.).
4. Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR).
5. The informed consent has been signed.

Exclusion Criteria

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

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

307 Hospital of PLA

OTHER

Sponsor Role collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role collaborator

Guilin Medical University, China

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Xi'an Central Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Locations

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Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wang, M.D

Role: CONTACT

8613816758802

Jie Gao, M.D

Role: CONTACT

8613761272863

Facility Contacts

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Dong Wang, MD

Role: primary

008613816758802

References

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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.

Reference Type RESULT
PMID: 26560036 (View on PubMed)

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.

Reference Type RESULT
PMID: 26867550 (View on PubMed)

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.

Reference Type RESULT
PMID: 27641243 (View on PubMed)

Other Identifiers

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LCI2018

Identifier Type: -

Identifier Source: org_study_id

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