NCT02926716

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

October 5, 2016

Last Update Submit

February 16, 2017

Conditions

Gastric Cancer

Keywords

Stomach neoplasmEndoscopyNarrow band imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Secondary Outcomes (2)

  • Tumor size

    2 weeks

  • Microvessel density

    4 weeks

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient who is diagnosed as early staged gastric cancer preoperatively

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwan, Gyeonggi-do, 443-749, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 24806114BACKGROUND

  • Kiyotoki 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.

    PMID: 20880172BACKGROUND

  • Yamada 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.

    PMID: 23932092BACKGROUND

  • Eleftheriadis 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.

    PMID: 24975679BACKGROUND

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Surgery, Ajou University School of Medicine

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 6, 2016

Study Start

December 14, 2015

Primary Completion

December 29, 2016

Study Completion

December 29, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

KR(1)