DyspepsiaNCT00673699
The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia
An observational study of Dyspepsia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Gastric mucosal biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Feb 2009
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hundred consecutive dyspeptic patients
Who may be able to join
- Dyspepsia
Who cannot join
- Pregnancy,
- Upper gastrointestinal bleeding,
- Previous gastric operation,
- Known gastric malignancy'
- Non cooperative patients
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Med Ctr
Hadera, 38100
Zvi Fireman, MD, +972-4-6304384, fireman@hy.health.gov.il
Yael Kopelman, MD
About this study
Official title: Observational: Studies in Human Beings Health Outcomes
The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia
Read the detailed description
To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.
- Conditions
- Dyspepsia
- Being tested
- Gastric mucosal biopsy
- Keywords
- NBI, gastroscopy, biopsy, intestinal metaplasia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric mucosal biopsyProcedure or surgery
Also called patients ith dyspepsia
Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia
| Study group | Role | What they receive |
|---|---|---|
| A | Seventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy Receives: Procedure: Gastric mucosal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if endoscope with NBI can detect intestinal metaplasia
Measured: In one week (the time from biopsy till the histology assement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Zvi Fireman, MD, Principal investigator, Hillel Yaffe Med Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673699
- Sponsor's protocol ID
- HY-07/2008
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hirata M, Tanaka S, Oka S, Kaneko I, Yoshida S, Yoshihara M, Chayama K. Evaluation of microvessels in colorectal tumors by narrow band imaging magnification. Gastrointest Endosc. 2007 Nov;66(5):945-52. doi: 10.1016/j.gie.2007.05.053.
PubMed 17963882
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational: Studies in Human Beings Health Outcomes
- ClinicalTrials.gov ID
- NCT00673699
- Acronym / sponsor ID
- HY-07/2008
- Conditions
- Dyspepsia
- Keywords
- NBI, gastroscopy, biopsy, intestinal metaplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 7 May 2008 (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.
The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia
Detailed description
To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Gastric mucosal biopsySeventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hundred consecutive dyspeptic patients
Key inclusion criteria (1 listed)
- Dyspepsia
Key exclusion criteria (5 listed)
- Pregnancy,
- Upper gastrointestinal bleeding,
- Previous gastric operation,
- Known gastric malignancy'
- Non cooperative patients
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 |
|---|---|---|
| Gastric mucosal biopsyAlso: patients ith dyspepsiaUsing upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia | Procedure or surgery | A |
Primary outcome
To determine if endoscope with NBI can detect intestinal metaplasia
Time frame: In one week (the time from biopsy till the histology assement)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Background: PubMed 17963882Hirata M, Tanaka S, Oka S, Kaneko I, Yoshida S, Yoshihara M, Chayama K. Evaluation of microvessels in colorectal tumors by narrow band imaging magnification. Gastrointest Endosc. 2007 Nov;66(5):945-52. doi: 10.1016/j.gie.2007.05.053.
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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.
Zvi Fireman, MD principal investigator
Hillel Yaffe Med Ctr
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 Dyspepsia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 5 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 7 May 2008. 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 Israel. 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 Zvi Fireman, MD (+972-4-6304384, fireman@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if endoscope with NBI can detect intestinal metaplasia (time frame: In one week (the time from biopsy till the histology assement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00673699, which also lists 1 linked publication.
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 7 May 2008.