Helicobacter Pylori InfectionNCT03011437
Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging
An observational study of Helicobacter Pylori Infection, run by Kashgar 1st People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esophagogastroduodenoscopy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- People who undergo esophagogastroduodenoscopy for possible upper gastrointestinal disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First People's Hospital of Kashgar Region
Kashgar, Xinjiang, 0998
Bai Yang, Doctor, 15626498226, baiyang1665@163.com
Bai Yang, Doctor
About this study
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.
Read the detailed description
Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections in man. And it is the causative factor for peptic ulcer and regarded as a class I carcinogen for gastric adenocarcinoma. Therefore, accurate detection of infection is crucial for devising proper eradication regimens and preventing the more severe GI complications. Detection of H. pylori in the gastric mucosa can be performed via (1) direct detection of the bacterium; culture, histology and polymerase chain reaction or (2) indirect detection of its enzymatic products particularly urease and serum H. pylori-specific antibody examinations. The direct detection methods are complicated and time-consuming. While the indirect detection methods are less accurate. With the wide use of endoscopy, diagnosis of H. pylori infection by endoscopy should be more accurate and easily available. However, there are still lack of endoscopic criteria for diagnosing H. pylori infection by conventional white light imaging (WLI), which correlates poorly with histopathological findings of H. pylori-induced gastritis . The newly modified LCI system (FUJIFILM Co.) can obtain clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light. LCI technique can enhance the color of the endoscopic images by digital processing, which makes red regions seem redder and white regions seem whiter. Therefore, LCI may facilitate the detection of certain kinds of gastric lesions. As the common thinking, H. pylori-associated gastritis regions are redder than normal mucosa under WLI because of hyperemia following inflammation. And such redness can be enhanced by LCI. However, there is no criterion for this estimating. Red, green and blue (RGB) color model is a basic component system of the hue, of which each color is a composition of different proportions. Thus, the color obtained by endoscopic images can be quantified by RGB model. The study aimed at comparing the ability of WLI and LCI for diagnosing H. pylori infection by using RGB color model and investigating objective and quantifiable endoscopic criteria for predicting H. pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esophagogastroduodenoscopy
- Keywords
- linked color imaging, Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopyOther
Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.
| Study group | Role | What they receive |
|---|---|---|
| cases | Patients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region. Receives: Other: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology
Measured: one month
Secondary outcomes (1)
Hp infection rate
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kashgar 1st People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Yang, Kashgar 1st People's Hospital
- Investigators
- Zou X Guang, Study chair, First People's Hospital of Kashgar Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011437
- Sponsor's protocol ID
- 2016A020212007
- Status last verified
- Jan 2017
- First submitted
- 28 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging
- ClinicalTrials.gov ID
- NCT03011437
- Acronym / sponsor ID
- 2016A020212007
- Conditions
- Helicobacter Pylori Infection
- Keywords
- linked color imaging, Helicobacter Pylori
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kashgar 1st People's HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections in man. And it is the causative factor for peptic ulcer and regarded as a class I carcinogen for gastric adenocarcinoma. Therefore, accurate detection of infection is crucial for devising proper eradication regimens and preventing the more severe GI complications. Detection of H. pylori in the gastric mucosa can be performed via (1) direct detection of the bacterium; culture, histology and polymerase chain reaction or (2) indirect detection of its enzymatic products particularly urease and serum H. pylori-specific antibody examinations. The direct detection methods are complicated and time-consuming. While the indirect detection methods are less accurate. With the wide use of endoscopy, diagnosis of H. pylori infection by endoscopy should be more accurate and easily available. However, there are still lack of endoscopic criteria for diagnosing H. pylori infection by conventional white light imaging (WLI), which correlates poorly with histopathological findings of H. pylori-induced gastritis . The newly modified LCI system (FUJIFILM Co.) can obtain clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light. LCI technique can enhance the color of the endoscopic images by digital processing, which makes red regions seem redder and white regions seem whiter. Therefore, LCI may facilitate the detection of certain kinds of gastric lesions. As the common thinking, H. pylori-associated gastritis regions are redder than normal mucosa under WLI because of hyperemia following inflammation. And such redness can be enhanced by LCI. However, there is no criterion for this estimating. Red, green and blue (RGB) color model is a basic component system of the hue, of which each color is a composition of different proportions. Thus, the color obtained by endoscopic images can be quantified by RGB model. The study aimed at comparing the ability of WLI and LCI for diagnosing H. pylori infection by using RGB color model and investigating objective and quantifiable endoscopic criteria for predicting H. pylori infection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: EsophagogastroduodenoscopyPatients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- People who undergo esophagogastroduodenoscopy for possible upper gastrointestinal disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopyEsophagogastroduodenoscopy is an examining method for upper gastrointestinal disease. | Other | cases |
Primary outcome
Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology
Time frame: one month
1 secondary outcome
Hp infection rate
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zou X Guang study chair
First People's Hospital of Kashgar Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Kashgar 1st People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bai Yang, Doctor (15626498226, baiyang1665@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.