Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging

NCT03011437 | Unknown DMC

• 1 other identifier: 2016A020212007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori) infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of LCI for diagnosing H. pylori infection compared with WLI.

Conditions

Helicobacter Pylori Infection

Keywords

linked color imaging; Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology

  one month

Secondary Outcomes (1)

• Hp infection rate

  one month

Study Arms (1)

cases

Patients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region.

Other: Esophagogastroduodenoscopy

Interventions

Esophagogastroduodenoscopy OTHER

Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.

cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who undergo esophagogastroduodenoscopy in the First People's Hospital of Kashgar Region. All patients provided written informed consents to undergo esophagogastroduodenoscopy and participate in this study.

You may qualify if:

• People who undergo esophagogastroduodenoscopy for possible upper gastrointestinal disease

You may not qualify if:

• Patients who have taken proton pump inhibitor, antibiotics, non-steroidal anti-inflammatory drugs, bismuth agent, H2-receptor inhibitor and medicines that can affect the test of H. pylori infection in a month
• Patients with severe systematic disorders
• Patients with accurate gastrointestinal bleeding in a week
• Patients with histories of gastric surgery
• Pregnant and lactating women
• Patients with poor coagulation function
• Patients diagnosed with gastric cancer

Sponsors & Collaborators

• Kashgar 1st People's Hospital: lead

Study Sites (1)

First People's Hospital of Kashgar Region

Kashgar, Xinjiang, 0998, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

gastric mucosa

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zou X Guang

  First People's Hospital of Kashgar Region

  STUDY CHAIR

Central Study Contacts

Bai Yang, Doctor

CONTACT

15626498226; baiyang1665@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 5, 2017
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)