Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

Gastric Disease Clinical Trial

Official title:

CMV Criteria in the Detection of Gastric Diseases Using Linked Color Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03092414
• Other study ID #: 307-LCI-004
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 25, 2017
• Start date: May 2017
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Xiaotian Sun, M.D., Ph.D.
• Email: xiaotian-sun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Based on previous experience, a new LCI based endoscopic diagnosis criteria called CMV (color- microstructure-vessel) criteria has been proposed, which could be used for judging the gastric mucosal lesions. LCI has the advantage of detecting color changes of the mucosa, and this could provide very valuable and useful evidence for making endoscopic diagnosis. In this study, a blinded random controlled clinical trial is designed to further validate the diagnostic value of LCI based CMV criteria for gastric diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years old patients

• Who agree to participate in the study

• Patients with the indications for gastroduodenoscopy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastric Disease
• Stomach Diseases

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Diagnostic accuracy of LCI for gastric diseases was calculated by comparing the LCI endoscopic diagnosis with pathological diagnosis.	4 months
Secondary	Numbers of lesions in the stomach	The numbers of lesion detected under WLE and LCI will be recorded and compared.	4 months
Secondary	Endoscopic examination duration	The time spent on the endoscopic examination using WLE and LCI will be compared.	4 months