Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy

Gastritis Clinical Trial

Official title:

Linked Color Imaging (LCI) System in the Identification of Normal Gastric Mucosa, Helicobacter Pylori Associated Gastritis and Gastric Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724280
• Other study ID #: 307-LCI-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: October 2018
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H. pylori infection plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens. The blind biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling errors. Most studies conclude that as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.

Description:

NBI is the most widely used system among several available image enhanced endoscopy systems. However, this technique has limitations such as dark imaging of distant lesions because of narrow-band illumination. Blue Laser Imaging (BLI) was developed to compensate for these inherent limitations of NBI. BLI uses narrow-band laser light combined with white light. This combination results in a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and the microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. 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, which means that BLI enables a clearer visualization of microvascular structures than does LCI. In contrast, 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. Therefore, LCI may facilitate the detection of H. pylori infection and gastric atrophy. Further studies are needed to confirm the utility of LCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: February 1, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• 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

• Atrophic Gastritis
• Atrophy
• Gastritis
• Gastritis, Atrophic
• Helicobacter Pylori Associated Gastritis

Intervention

Device:
• 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 (5)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	People's Hospital of Guangxi, Second Affiliated Hospital of Soochow University, Shanghai 10th People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Anagnostopoulos GK, Yao K, Kaye P, Fogden E, Fortun P, Shonde A, Foley S, Sunil S, Atherton JJ, Hawkey C, Ragunath K. High-resolution magnification endoscopy can reliably identify normal gastric mucosa, Helicobacter pylori-associated gastritis, and gastri — View Citation

Yao K, Anagnostopoulos GK, Ragunath K. Magnifying endoscopy for diagnosing and delineating early gastric cancer. Endoscopy. 2009 May;41(5):462-7. doi: 10.1055/s-0029-1214594. Epub 2009 May 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis rate of normal gastric mucosa, H. pylori associated gastritis and gastric atrophy	Number of patients with normal gastric mucosa, H. pylori associated gastritis and gastric atrophy will be calculated.	6 months