NCT03092414

Brief Summary

The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

March 21, 2017

Last Update Submit

March 25, 2017

Conditions

Gastric Disease

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Diagnostic accuracy of LCI for gastric diseases was calculated by comparing the LCI endoscopic diagnosis with pathological diagnosis.

    4 months

Secondary Outcomes (2)

  • Numbers of lesions in the stomach

    4 months

  • Endoscopic examination duration

    4 months

Study Arms (2)

Group A

EXPERIMENTAL

Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.

Procedure: WLE and then LCI

Group B

EXPERIMENTAL

Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.

Procedure: LCI and then WLE

Interventions

WLE and then LCIPROCEDURE

The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.

Group A
LCI and then WLEPROCEDURE

The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years old patients
  • Who agree to participate in the study
  • Patients with the indications for gastroduodenoscopy

You may not qualify if:

  • Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
  • Severe uncontrolled coagulopathy
  • Prior history of gastric surgery.
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

Location

Related Publications (4)

  • 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.

    PMID: 27641243BACKGROUND

  • Dohi O, Yagi N, Onozawa Y, Kimura-Tsuchiya R, Majima A, Kitaichi T, Horii Y, Suzuki K, Tomie A, Okayama T, Yoshida N, Kamada K, Katada K, Uchiyama K, Ishikawa T, Takagi T, Handa O, Konishi H, Naito Y, Itoh Y. Linked color imaging improves endoscopic diagnosis of active Helicobacter pylori infection. Endosc Int Open. 2016 Jul;4(7):E800-5. doi: 10.1055/s-0042-109049.

    PMID: 27556101BACKGROUND

  • Ono S, Abiko S, Kato M. Linked color imaging enhances gastric cancer in gastric intestinal metaplasia. Dig Endosc. 2017 Mar;29(2):230-231. doi: 10.1111/den.12757. Epub 2016 Nov 21. No abstract available.

    PMID: 27770584BACKGROUND

  • Min M, Dong TH, Liu Y, Bi YL, Ma CY. Novel endoscopic findings as visualized by non-magnification endoscopy with linked color imaging are indicative of gastric intestinal metaplasia. Chin Med J (Engl). 2019 Apr 5;132(7):782-788. doi: 10.1097/CM9.0000000000000172.

    PMID: 30896610DERIVED

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yan Liu, M.D., Ph.D.

    Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotian Sun, M.D., Ph.D.

CONTACT

xiaotian-sun@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

May 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)