Early Gastric CancerNCT03546257
Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study
An observational study of Early Gastric Cancer and Gastric Adenoma, run by Yonsei University.
Trial summary
The treatment of early gastric cancer can be divided into endoscopic resection and surgery, and the precise staging of early gastric cancer is very important to prevent unnecessary surgery or additional surgery after the procedure. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenoma, Gastric Dysplasia
- What is being tested?
- magnifying endoscopy with narrow band imaging (ME-NBI)
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Apr 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Adults over 19 years of age
- Patients who are diagnosed gastric adenoma or early gastric cancer by esophagogastroduodenoscopy and are planning endoscopic resection or surgical resection for cure.
- Patients who understand that they have the right to sign the consent form prior to the initiation of treatment and to withdraw from the clinical trial without penalty at any time.
Who cannot join
- Failed to obtain informed consent of the patient or guardian.
- Anyone deemed inappropriate by the researchers or the primary care physician in clinical studies.
- Women who are pregnant and possibly pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
The treatment of early gastric cancer can be divided into endoscopic resection and surgery, and the precise staging of early gastric cancer is very important to prevent unnecessary surgery or additional surgery after the procedure. The possibility of endoscopic resection is determined by the risk of lymph node metastasis. The risk factors of lymph node metastasis of early gastric cancer are lesion size, presence of ulceration, histologic differentiation, and depth of invasion. In contrast to other factors, the factor of invasion depth is relatively difficult to predict by using the conventional white light endoscopy (WLE). Therefore, the endoscopic ultrasonography (EUS) has been tried to use for prediction of the invasion depth. However, many studies reported that the accuracy of endoscopic ultrasonography for predicting the depth of invasion was varied.
A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.
In this study, we divide the patients with suspected early gastric cancer (EGC) into the two groups as group using conventional WLE and EUS and group using WLE and ME-NBI, and try to compare the accuracy of EUS and ME-NBI for predicting the invasion depth of EGC. We also try to analyze the factors that affect the accuracy for predicting of depth such as characteristics of cancer lesion and histologic differentiation of cancer in each group. In addition, we try to analyze the characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma and evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.
Read the detailed description
The subjects is divided into early gastric cancer patients and gastric adenoma patients according to histologic biopsy result and white light endoscopic findings. Study 1 applies for early gastric cancer patients, Study 2 applies for gastric adenoma patients.
- Study 1 The NBI group performs ME-NBI first before EUS. The endoscopist evaluates NBI findings such as the invasion depth and describes ME-NBI impression. And then, EUS is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.
The EUS group performs EUS first before NBI. The endoscopist evaluates EUS findings such as the invasion depth and describes EUS impression. And then, ME-NBI is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.
According to clinical stage of early gastric cancer, endoscopic resection is performed in case of endoscopic resection indication or beyond indication but case of having the risk of surgery according to patient status. The surgical resection is performed if the patient wants surgery or does not meet the indications of endoscopic resection.
The pathologist performs a histological evaluation of the resected gastric cancer lesion, including an invasive depth.
- Study 2 First, the endoscopist performs WLE and describes WLE findings and impression such as location, size, and gross morphology of lesion. The same examiner performs ME-NBI and describes ME-NBI findings and impression such as mucosal pattern, predicted degree of dysplasia.
Endoscopic resection or surgical resection is performed according to the results of histologic result of gastric adenoma.
The pathologist performs a histological evaluation of the resected dysplastic lesion.
- Conditions
- Early Gastric Cancer, Gastric Adenoma, Gastric Dysplasia
- Being tested
- magnifying endoscopy with narrow band imaging (ME-NBI)
- Keywords
- Early gastric cancer, Invasion depth, Narrow band imaging, Endoscopic ultrasonography
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnifying endoscopy with narrow band imaging (ME-NBI)Device
A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.
| Study group | Role | What they receive |
|---|---|---|
| EUS | group using conventional WLE and EUS | |
| ME-NBI | group using WLE and ME-NBI. Receives: Device: magnifying endoscopy with narrow band imaging (ME-NBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy in predicting the invasion depth of EGC.
To compare the accuracy of EUS and ME-NBI in predicting the invasion depth of EGC using final pathology result.
Measured: Within 1 month after lesion resection
Secondary outcomes (1)
The NBI findings that affect the accuracy for predicting of depth.
The characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma such as microvessels, pits, histological patterns.
For example) ME-NBI classification Type A : clear regular surface patterns and microvascular architecture. Type B : obscure irregular surface patterns or microvascular architecture. Type C :no surface pattern and sparse microvessels or with avascular areas. Finally, to evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.
Measured: Within 1 month after lesion resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startMar 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546257
- Sponsor's protocol ID
- 4-2018-0220
- Status last verified
- Feb 2019
- First submitted
- 21 May 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information related to this study will be used purely for research purposes and all data will be encrypted and strictly kept confidential and protected. In order to protect the personal information of the patient, information about the patient's identity and information about the patient will be managed as independent data.
Publications
Choi J, Kim SG, Im JP, Kim JS, Jung HC, Song IS. Endoscopic prediction of tumor invasion depth in early gastric cancer. Gastrointest Endosc. 2011 May;73(5):917-27. doi: 10.1016/j.gie.2010.11.053. Epub 2011 Feb 11.
PubMed 21316050Pei Q, Wang L, Pan J, Ling T, Lv Y, Zou X. Endoscopic ultrasonography for staging depth of invasion in early gastric cancer: A meta-analysis. J Gastroenterol Hepatol. 2015 Nov;30(11):1566-73. doi: 10.1111/jgh.13014.
PubMed 26094975Kwee RM, Kwee TC. The accuracy of endoscopic ultrasonography in differentiating mucosal from deeper gastric cancer. Am J Gastroenterol. 2008 Jul;103(7):1801-9. doi: 10.1111/j.1572-0241.2008.01923.x. Epub 2008 Jun 28.
PubMed 18564110Serrano OK, Huang K, Ng N, Yang J, Friedmann P, Libutti SK, Kennedy TJ. Correlation between preoperative endoscopic ultrasound and surgical pathology staging of gastric adenocarcinoma: A single institution retrospective review. J Surg Oncol. 2016 Jan;113(1):42-5. doi: 10.1002/jso.24098. Epub 2016 Jan 19.
PubMed 26784562Gono K. Narrow Band Imaging: Technology Basis and Research and Development History. Clin Endosc. 2015 Nov;48(6):476-80. doi: 10.5946/ce.2015.48.6.476. Epub 2015 Nov 30.
PubMed 26668792Hayee B, Inoue H, Sato H, Santi EG, Yoshida A, Onimaru M, Ikeda H, Kudo SE. Magnification narrow-band imaging for the diagnosis of early gastric cancer: a review of the Japanese literature for the Western endoscopist. Gastrointest Endosc. 2013 Sep;78(3):452-61. doi: 10.1016/j.gie.2013.03.1333. Epub 2013 Apr 28. No abstract available.
PubMed 23632326Kikuchi D, Iizuka T, Hoteya S, Yamada A, Furuhata T, Yamashita S, Domon K, Nakamura M, Matsui A, Mitani T, Ogawa O, Watanabe S, Kaise M. Usefulness of magnifying endoscopy with narrow-band imaging for determining tumor invasion depth in early gastric cancer. Gastroenterol Res Pract. 2013;2013:217695. doi: 10.1155/2013/217695. Epub 2013 Jan 17.
PubMed 23401676Yagi K, Saka A, Nozawa Y, Nakamura A, Umezu H. Prediction of submucosal gastric cancer by narrow-band imaging magnifying endoscopy. Dig Liver Dis. 2014 Feb;46(2):187-90. doi: 10.1016/j.dld.2013.09.003. Epub 2013 Oct 21.
PubMed 24157380Jang JY. The Usefulness of Magnifying Endoscopy and Narrow-Band Imaging in Measuring the Depth of Invasion before Endoscopic Submucosal Dissection. Clin Endosc. 2012 Nov;45(4):379-85. doi: 10.5946/ce.2012.45.4.379. Epub 2012 Nov 30.
PubMed 23251885Kobara H, Mori H, Fujihara S, Kobayashi M, Nishiyama N, Nomura T, Kato K, Ishihara S, Morito T, Mizobuchi K, Iwama H, Masaki T. Prediction of invasion depth for submucosal differentiated gastric cancer by magnifying endoscopy with narrow-band imaging. Oncol Rep. 2012 Sep;28(3):841-7. doi: 10.3892/or.2012.1889. Epub 2012 Jun 26.
PubMed 22752002Spolverato G, Ejaz A, Kim Y, Squires MH, Poultsides GA, Fields RC, Schmidt C, Weber SM, Votanopoulos K, Maithel SK, Pawlik TM. Use of endoscopic ultrasound in the preoperative staging of gastric cancer: a multi-institutional study of the US gastric cancer collaborative. J Am Coll Surg. 2015 Jan;220(1):48-56. doi: 10.1016/j.jamcollsurg.2014.06.023. Epub 2014 Jul 18.
PubMed 25283742Li HY, Dai J, Xue HB, Zhao YJ, Chen XY, Gao YJ, Song Y, Ge ZZ, Li XB. Application of magnifying endoscopy with narrow-band imaging in diagnosing gastric lesions: a prospective study. Gastrointest Endosc. 2012 Dec;76(6):1124-32. doi: 10.1016/j.gie.2012.08.015. Epub 2012 Sep 29.
PubMed 23025977Nonaka T, Inamori M, Honda Y, Kanoshima K, Inoh Y, Matsuura M, Uchiyama S, Sakai E, Higurashi T, Ohkubo H, Iida H, Endo H, Fujita K, Kusakabe A, Atsukawa K, Takahashi H, Tateishi Y, Maeda S, Ohashi K, Nakajima A. Can magnifying endoscopy with narrow-band imaging discriminate between carcinomas and low grade adenomas in gastric superficial elevated lesions? Endosc Int Open. 2016 Nov;4(11):E1203-E1210. doi: 10.1055/s-0042-117632. Epub 2016 Oct 20.
PubMed 27853747Yoshifuku Y, Sanomura Y, Oka S, Kuroki K, Kurihara M, Mizumoto T, Urabe Y, Hiyama T, Tanaka S, Chayama K. Clinical Usefulness of the VS Classification System Using Magnifying Endoscopy with Blue Laser Imaging for Early Gastric Cancer. Gastroenterol Res Pract. 2017;2017:3649705. doi: 10.1155/2017/3649705. Epub 2017 May 15.
PubMed 28596787
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT03546257
- Acronym / sponsor ID
- 4-2018-0220
- Conditions
- Early Gastric Cancer, Gastric Adenoma, Gastric Dysplasia
- Keywords
- Early gastric cancer, Invasion depth, Narrow band imaging, Endoscopic ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Jun 2018 (actual)
- 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 treatment of early gastric cancer can be divided into endoscopic resection and surgery, and the precise staging of early gastric cancer is very important to prevent unnecessary surgery or additional surgery after the procedure. The possibility of endoscopic resection is determined by the risk of lymph node metastasis. The risk factors of lymph node metastasis of early gastric cancer are lesion size, presence of ulceration, histologic differentiation, and depth of invasion. In contrast to other factors, the factor of invasion depth is relatively difficult to predict by using the conventional white light endoscopy (WLE). Therefore, the endoscopic ultrasonography (EUS) has been tried to use for prediction of the invasion depth. However, many studies reported that the accuracy of endoscopic ultrasonography for predicting the depth of invasion was varied.
A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.
In this study, we divide the patients with suspected early gastric cancer (EGC) into the two groups as group using conventional WLE and EUS and group using WLE and ME-NBI, and try to compare the accuracy of EUS and ME-NBI for predicting the invasion depth of EGC. We also try to analyze the factors that affect the accuracy for predicting of depth such as characteristics of cancer lesion and histologic differentiation of cancer in each group. In addition, we try to analyze the characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma and evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.
Detailed description
The subjects is divided into early gastric cancer patients and gastric adenoma patients according to histologic biopsy result and white light endoscopic findings. Study 1 applies for early gastric cancer patients, Study 2 applies for gastric adenoma patients.
- Study 1 The NBI group performs ME-NBI first before EUS. The endoscopist evaluates NBI findings such as the invasion depth and describes ME-NBI impression. And then, EUS is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.
The EUS group performs EUS first before NBI. The endoscopist evaluates EUS findings such as the invasion depth and describes EUS impression. And then, ME-NBI is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.
According to clinical stage of early gastric cancer, endoscopic resection is performed in case of endoscopic resection indication or beyond indication but case of having the risk of surgery according to patient status. The surgical resection is performed if the patient wants surgery or does not meet the indications of endoscopic resection.
The pathologist performs a histological evaluation of the resected gastric cancer lesion, including an invasive depth.
- Study 2 First, the endoscopist performs WLE and describes WLE findings and impression such as location, size, and gross morphology of lesion. The same examiner performs ME-NBI and describes ME-NBI findings and impression such as mucosal pattern, predicted degree of dysplasia.
Endoscopic resection or surgical resection is performed according to the results of histologic result of gastric adenoma.
The pathologist performs a histological evaluation of the resected dysplastic lesion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS | – | –group using conventional WLE and EUS |
| ME-NBI | – | Device: magnifying endoscopy with narrow band imaging (ME-NBI)group using WLE and ME-NBI. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Adults over 19 years of age
- Patients who are diagnosed gastric adenoma or early gastric cancer by esophagogastroduodenoscopy and are planning endoscopic resection or surgical resection for cure.
- Patients who understand that they have the right to sign the consent form prior to the initiation of treatment and to withdraw from the clinical trial without penalty at any time.
Key exclusion criteria (3 listed)
- Failed to obtain informed consent of the patient or guardian.
- Anyone deemed inappropriate by the researchers or the primary care physician in clinical studies.
- Women who are pregnant and possibly pregnant or breastfeeding
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 |
|---|---|---|
| magnifying endoscopy with narrow band imaging (ME-NBI)A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE. | Device | ME-NBI |
Primary outcome
the accuracy in predicting the invasion depth of EGC.
Time frame: Within 1 month after lesion resection
To compare the accuracy of EUS and ME-NBI in predicting the invasion depth of EGC using final pathology result.
1 secondary outcome
The NBI findings that affect the accuracy for predicting of depth.
Time frame: Within 1 month after lesion resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Results publication: PubMed 21316050Choi J, Kim SG, Im JP, Kim JS, Jung HC, Song IS. Endoscopic prediction of tumor invasion depth in early gastric cancer. Gastrointest Endosc. 2011 May;73(5):917-27. doi: 10.1016/j.gie.2010.11.053. Epub 2011 Feb 11.
- Results publication: PubMed 26094975Pei Q, Wang L, Pan J, Ling T, Lv Y, Zou X. Endoscopic ultrasonography for staging depth of invasion in early gastric cancer: A meta-analysis. J Gastroenterol Hepatol. 2015 Nov;30(11):1566-73. doi: 10.1111/jgh.13014.
- Results publication: PubMed 18564110Kwee RM, Kwee TC. The accuracy of endoscopic ultrasonography in differentiating mucosal from deeper gastric cancer. Am J Gastroenterol. 2008 Jul;103(7):1801-9. doi: 10.1111/j.1572-0241.2008.01923.x. Epub 2008 Jun 28.
- Results publication: PubMed 26784562Serrano OK, Huang K, Ng N, Yang J, Friedmann P, Libutti SK, Kennedy TJ. Correlation between preoperative endoscopic ultrasound and surgical pathology staging of gastric adenocarcinoma: A single institution retrospective review. J Surg Oncol. 2016 Jan;113(1):42-5. doi: 10.1002/jso.24098. Epub 2016 Jan 19.
- Results publication: PubMed 26668792Gono K. Narrow Band Imaging: Technology Basis and Research and Development History. Clin Endosc. 2015 Nov;48(6):476-80. doi: 10.5946/ce.2015.48.6.476. Epub 2015 Nov 30.
- Results publication: PubMed 23632326Hayee B, Inoue H, Sato H, Santi EG, Yoshida A, Onimaru M, Ikeda H, Kudo SE. Magnification narrow-band imaging for the diagnosis of early gastric cancer: a review of the Japanese literature for the Western endoscopist. Gastrointest Endosc. 2013 Sep;78(3):452-61. doi: 10.1016/j.gie.2013.03.1333. Epub 2013 Apr 28. No abstract available.
- Results publication: PubMed 23401676Kikuchi D, Iizuka T, Hoteya S, Yamada A, Furuhata T, Yamashita S, Domon K, Nakamura M, Matsui A, Mitani T, Ogawa O, Watanabe S, Kaise M. Usefulness of magnifying endoscopy with narrow-band imaging for determining tumor invasion depth in early gastric cancer. Gastroenterol Res Pract. 2013;2013:217695. doi: 10.1155/2013/217695. Epub 2013 Jan 17.
- Results publication: PubMed 24157380Yagi K, Saka A, Nozawa Y, Nakamura A, Umezu H. Prediction of submucosal gastric cancer by narrow-band imaging magnifying endoscopy. Dig Liver Dis. 2014 Feb;46(2):187-90. doi: 10.1016/j.dld.2013.09.003. Epub 2013 Oct 21.
- Results publication: PubMed 23251885Jang JY. The Usefulness of Magnifying Endoscopy and Narrow-Band Imaging in Measuring the Depth of Invasion before Endoscopic Submucosal Dissection. Clin Endosc. 2012 Nov;45(4):379-85. doi: 10.5946/ce.2012.45.4.379. Epub 2012 Nov 30.
- Results publication: PubMed 22752002Kobara H, Mori H, Fujihara S, Kobayashi M, Nishiyama N, Nomura T, Kato K, Ishihara S, Morito T, Mizobuchi K, Iwama H, Masaki T. Prediction of invasion depth for submucosal differentiated gastric cancer by magnifying endoscopy with narrow-band imaging. Oncol Rep. 2012 Sep;28(3):841-7. doi: 10.3892/or.2012.1889. Epub 2012 Jun 26.
- Results publication: PubMed 25283742Spolverato G, Ejaz A, Kim Y, Squires MH, Poultsides GA, Fields RC, Schmidt C, Weber SM, Votanopoulos K, Maithel SK, Pawlik TM. Use of endoscopic ultrasound in the preoperative staging of gastric cancer: a multi-institutional study of the US gastric cancer collaborative. J Am Coll Surg. 2015 Jan;220(1):48-56. doi: 10.1016/j.jamcollsurg.2014.06.023. Epub 2014 Jul 18.
- Results publication: PubMed 23025977Li HY, Dai J, Xue HB, Zhao YJ, Chen XY, Gao YJ, Song Y, Ge ZZ, Li XB. Application of magnifying endoscopy with narrow-band imaging in diagnosing gastric lesions: a prospective study. Gastrointest Endosc. 2012 Dec;76(6):1124-32. doi: 10.1016/j.gie.2012.08.015. Epub 2012 Sep 29.
- Individual participant dataSharing planned: No. The information related to this study will be used purely for research purposes and all data will be encrypted and strictly kept confidential and protected. In order to protect the personal information of the patient, information about the patient's identity and information about the patient will be managed as independent data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer and Gastric Adenoma, run by Yonsei University.
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 3 inclusion and 3 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Chul Park (+82-02-2228-5201, JUNCHUL75@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy in predicting the invasion depth of EGC. (time frame: Within 1 month after lesion resection). 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 NCT03546257, which also lists 14 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 11 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.