Gastric TumorsNCT02661945
Usefulness of Near-focus With Narrow-band Imaging
A study testing Near focus with narrow band imaging in people with Gastric Tumors, run by Kyunghee University Medical Center at 7 sites in South Korea.
Trial summary
Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Tumors
- What is being tested?
- Near focus with narrow band imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Jul 2015to Aug 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)
Who cannot join
- fail to en bloc resection
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Cheonan Hospital, Soonchunhyang University College of Medicine
Cheonan, Chungcheongnam-do
Inha University School of Medicine
Incheon
Pusan National University School of Medicine
Pusan
Korea University Medical Center
Seoul, Seongbuk-gu, 02841
Kyung Hee University Hospital
Seoul, 130-872
Severance Hospital, Yonsei University College of Medicine
Seoul
Soonchunhyang University Hospital
Seoul
About this study
Official title: Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin
Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.
- Conditions
- Gastric Tumors
- Being tested
- Near focus with narrow band imaging
- Keywords
- near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near focus with narrow band imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| Near focus with narrow band imaging | Experimental | Near focus with narrow band imaging is used for marking the tumor margin. Receives: Device: Near focus with narrow band imaging |
| Indigo carmin | No intervention | After indigo carmine was sprayed over the lesion, marking is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)
Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm
Measured: 1 week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric TumorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Wook Kim, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661945
- Sponsor's protocol ID
- NFNBI
- Status last verified
- May 2019
- First submitted
- 20 Jan 2016
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nagahama T, Yao K, Maki S, Yasaka M, Takaki Y, Matsui T, Tanabe H, Iwashita A, Ota A. Usefulness of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy (with video). Gastrointest Endosc. 2011 Dec;74(6):1259-67. doi: 10.1016/j.gie.2011.09.005.
PubMed 22136775Kiyotoki S, Nishikawa J, Satake M, Fukagawa Y, Shirai Y, Hamabe K, Saito M, Okamoto T, Sakaida I. Usefulness of magnifying endoscopy with narrow-band imaging for determining gastric tumor margin. J Gastroenterol Hepatol. 2010 Oct;25(10):1636-41. doi: 10.1111/j.1440-1746.2010.06379.x.
PubMed 20880172Kim JW, Jung Y, Jang JY, Kim GH, Bang BW, Park JC, Choi HS, Cho JH; Research Group for Endoscopic Instruments and Stents of Korean Society of Gastrointestinal Endoscopy. Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial. J Gastroenterol Hepatol. 2020 Nov;35(11):1930-1937. doi: 10.1111/jgh.15109. Epub 2020 Jun 16.
PubMed 32433790
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin
- ClinicalTrials.gov ID
- NCT02661945
- Acronym / sponsor ID
- NFNBI
- Conditions
- Gastric Tumors
- Keywords
- near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 25 Jan 2016 (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.
Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near focus with narrow band imaging | Experimental | Device: Near focus with narrow band imagingNear focus with narrow band imaging is used for marking the tumor margin. |
| Indigo carmin | No intervention | –After indigo carmine was sprayed over the lesion, marking is performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)
Key exclusion criteria (1 listed)
- fail to en bloc resection
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 |
|---|---|---|
| Near focus with narrow band imaging | Device | Near focus with narrow band imaging |
Primary outcome
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)
Time frame: 1 week after procedure
Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 22136775Nagahama T, Yao K, Maki S, Yasaka M, Takaki Y, Matsui T, Tanabe H, Iwashita A, Ota A. Usefulness of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy (with video). Gastrointest Endosc. 2011 Dec;74(6):1259-67. doi: 10.1016/j.gie.2011.09.005.
- Results publication: PubMed 20880172Kiyotoki S, Nishikawa J, Satake M, Fukagawa Y, Shirai Y, Hamabe K, Saito M, Okamoto T, Sakaida I. Usefulness of magnifying endoscopy with narrow-band imaging for determining gastric tumor margin. J Gastroenterol Hepatol. 2010 Oct;25(10):1636-41. doi: 10.1111/j.1440-1746.2010.06379.x.
- Derived from this study: PubMed 32433790Kim JW, Jung Y, Jang JY, Kim GH, Bang BW, Park JC, Choi HS, Cho JH; Research Group for Endoscopic Instruments and Stents of Korean Society of Gastrointestinal Endoscopy. Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial. J Gastroenterol Hepatol. 2020 Nov;35(11):1930-1937. doi: 10.1111/jgh.15109. Epub 2020 Jun 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near focus with narrow band imaging in people with Gastric Tumors, run by Kyunghee University Medical Center at 7 sites in South Korea.
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 1 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: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm) (time frame: 1 week after procedure). 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 NCT02661945, which also lists 3 linked publications.
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 4 Jun 2019.