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

Primary Purpose

Gastritis, Helicobacter Pylori Associated Gastritis, Atrophic Gastritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WLE and then LCI
LCI and then WLE
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital to Academy of Military Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2016
Last Updated
October 30, 2018
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
People's Hospital of Guangxi, Shanghai 10th People's Hospital, Second Affiliated Hospital of Soochow University, Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02724280
Brief Title
Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy
Official Title
Linked Color Imaging (LCI) System in the Identification of Normal Gastric Mucosa, Helicobacter Pylori Associated Gastritis and Gastric Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
People's Hospital of Guangxi, Shanghai 10th People's Hospital, Second Affiliated Hospital of Soochow University, Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis, Helicobacter Pylori Associated Gastritis, Atrophic Gastritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.
Intervention Type
Device
Intervention Name(s)
WLE and then LCI
Other Intervention Name(s)
White light endoscopy (WLE) / linked color imaging (LCI)
Intervention Description
The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.
Intervention Type
Device
Intervention Name(s)
LCI and then WLE
Other Intervention Name(s)
Linked color imaging (LCI) / White light endoscopy (WLE)
Intervention Description
The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.
Primary Outcome Measure Information:
Title
Diagnosis rate of normal gastric mucosa, H. pylori associated gastritis and gastric atrophy
Description
Number of patients with normal gastric mucosa, H. pylori associated gastritis and gastric atrophy will be calculated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, M.D., Ph.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17273960
Citation
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 gastric atrophy. Endoscopy. 2007 Mar;39(3):202-7. doi: 10.1055/s-2006-945056. Epub 2007 Feb 1.
Results Reference
result
PubMed Identifier
19418401
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.
Results Reference
result

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

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