Gastric CancerNCT02926716
NBI for Identifying Resection Margin Status in Gastric Cancer
An observational study of Gastric Cancer, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
As the proportion of early gastric cancer has been steadily increased in Korea, so has function-preserving surgery. The function preserving surgery is characterized by the minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter than those of standard gastrectomies. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2015to 29 Dec 2016
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient who is diagnosed as early staged gastric cancer preoperatively
Who may be able to join
- The patient from over 20 to under 90 years
- The patient who is diagnosed as gastric cancer clinically by endoscopy or computed tomography
- The patient who is informed and consent about the purpose and contents of this study prior to the participation in this study
Who cannot join
- The patient who shows far advanced gastric cancer preoperatively or intraoperatively
- The patient with previous medical history of other treatment for gastric caner such as endoscopic resection, chemotherapy, radiation, immunotherapy, and so on
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou University School of Medicine
Suwan, Gyeonggi-do, 443-749
About this study
Official title: Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer
As the proportion of early gastric cancer has been steadily increased in Korea, so has function-preserving surgery. The function preserving surgery is characterized by the minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter than those of standard gastrectomies.
Currently, there is only one way to identify resection margin status in gastric cancer, 'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition, the results rely on the pathologist's expertise, thereby it showed limitation of its accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous study.
Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated that this emerging technique is useful to identify the gastric tumor margin more clearly in vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that NBI may allow reliable delineation of tumor and identification of resection margin status in the specimen after gastrectomy for gastric cancer.
Read the detailed description
- Tumor delineation and identification of resection margin: After specimen delivery from the abdomen, frozen biopsy is performed before checking tumor margin. After inspection with NBI, the tumor margin is marked with electrocauterization. The tumor size and the lengths of both resection margins are evaluated using a ruler.
- Pathologic examination:
The specimen is sliced as 4mm interval paralleled to the markings. Tumor size, the status of both resection margins, and microvessel density are evaluated under the 200 magnified view.
- Conditions
- Gastric Cancer
- Keywords
- Stomach neoplasm, Endoscopy, Narrow band imaging
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy for identifying the status of resection margin
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
Measured: 2 weeks
Secondary outcomes (2)
Tumor size
The tumor size assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
Measured: 2 weeks
Microvessel density
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start14 Dec 2015
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Uk Han, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926716
- Sponsor's protocol ID
- AJIRB-MED-SMP-15-10
- Status last verified
- Feb 2017
- First submitted
- 5 Oct 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
Publications
Spicer J, Benay C, Lee L, Rousseau M, Andalib A, Kushner Y, Marcus V, Ferri L. Diagnostic accuracy and utility of intraoperative microscopic margin analysis of gastric and esophageal adenocarcinoma. Ann Surg Oncol. 2014 Aug;21(8):2580-6. doi: 10.1245/s10434-014-3669-7. Epub 2014 May 8.
PubMed 24806114Kiyotoki 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 20880172Yamada S, Doyama H, Yao K, Uedo N, Ezoe Y, Oda I, Kaneko K, Kawahara Y, Yokoi C, Sugiura Y, Ishikawa H, Takeuchi Y, Saito Y, Muto M. An efficient diagnostic strategy for small, depressed early gastric cancer with magnifying narrow-band imaging: a post-hoc analysis of a prospective randomized controlled trial. Gastrointest Endosc. 2014 Jan;79(1):55-63. doi: 10.1016/j.gie.2013.07.008. Epub 2013 Aug 7.
PubMed 23932092Eleftheriadis N, Inoue H, Ikeda H, Maselli R, Onimaru M, Yoshida A, Ito H, Hamatani S, Kudo SE. Improved optical identification of laterally spreading type "0-IIb" gastric lesion with narrow band imaging magnification endoscopy. Ann Gastroenterol. 2014;27(3):267-269.
PubMed 24975679
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02926716
- Acronym / sponsor ID
- AJIRB-MED-SMP-15-10
- Conditions
- Gastric Cancer
- Keywords
- Stomach neoplasm, Endoscopy, Narrow band imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 6 Oct 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.
As the proportion of early gastric cancer has been steadily increased in Korea, so has function-preserving surgery. The function preserving surgery is characterized by the minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter than those of standard gastrectomies.
Currently, there is only one way to identify resection margin status in gastric cancer, 'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition, the results rely on the pathologist's expertise, thereby it showed limitation of its accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous study.
Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated that this emerging technique is useful to identify the gastric tumor margin more clearly in vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that NBI may allow reliable delineation of tumor and identification of resection margin status in the specimen after gastrectomy for gastric cancer.
Detailed description
- Tumor delineation and identification of resection margin: After specimen delivery from the abdomen, frozen biopsy is performed before checking tumor margin. After inspection with NBI, the tumor margin is marked with electrocauterization. The tumor size and the lengths of both resection margins are evaluated using a ruler.
- Pathologic examination:
The specimen is sliced as 4mm interval paralleled to the markings. Tumor size, the status of both resection margins, and microvessel density are evaluated under the 200 magnified view.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient who is diagnosed as early staged gastric cancer preoperatively
Key inclusion criteria (3 listed)
- The patient from over 20 to under 90 years
- The patient who is diagnosed as gastric cancer clinically by endoscopy or computed tomography
- The patient who is informed and consent about the purpose and contents of this study prior to the participation in this study
Key exclusion criteria (2 listed)
- The patient who shows far advanced gastric cancer preoperatively or intraoperatively
- The patient with previous medical history of other treatment for gastric caner such as endoscopic resection, chemotherapy, radiation, immunotherapy, and so on
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy for identifying the status of resection margin
Time frame: 2 weeks
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
2 secondary outcomes
Tumor size
Time frame: 2 weeks
Microvessel density
Time frame: 4 weeks
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 17 Feb 2017.
- Background: PubMed 24806114Spicer J, Benay C, Lee L, Rousseau M, Andalib A, Kushner Y, Marcus V, Ferri L. Diagnostic accuracy and utility of intraoperative microscopic margin analysis of gastric and esophageal adenocarcinoma. Ann Surg Oncol. 2014 Aug;21(8):2580-6. doi: 10.1245/s10434-014-3669-7. Epub 2014 May 8.
- Background: 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.
- Background: PubMed 23932092Yamada S, Doyama H, Yao K, Uedo N, Ezoe Y, Oda I, Kaneko K, Kawahara Y, Yokoi C, Sugiura Y, Ishikawa H, Takeuchi Y, Saito Y, Muto M. An efficient diagnostic strategy for small, depressed early gastric cancer with magnifying narrow-band imaging: a post-hoc analysis of a prospective randomized controlled trial. Gastrointest Endosc. 2014 Jan;79(1):55-63. doi: 10.1016/j.gie.2013.07.008. Epub 2013 Aug 7.
- Background: PubMed 24975679Eleftheriadis N, Inoue H, Ikeda H, Maselli R, Onimaru M, Yoshida A, Ito H, Hamatani S, Kudo SE. Improved optical identification of laterally spreading type "0-IIb" gastric lesion with narrow band imaging magnification endoscopy. Ann Gastroenterol. 2014;27(3):267-269.
- Institutional Review Board, Ajou University HospitalLink provided by the sponsor.
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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.
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 Gastric Cancer, run by Ajou University School of Medicine at 1 site 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 3 inclusion and 2 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 17 Feb 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 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 for identifying the status of resection margin (time frame: 2 weeks). 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 NCT02926716, which also lists 4 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 17 Feb 2017.