NBI for Identifying Resection Margin Status in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926716
• Other study ID #: AJIRB-MED-SMP-15-10
• Status: Completed
• Phase: N/A
• First received: October 5, 2016
• Last updated: February 16, 2017
• Start date: December 14, 2015
• Est. completion date: December 29, 2016

Study information

• Verified date: February 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 29, 2016
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwan	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tumor size	The tumor size assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks	2 weeks
Secondary	Microvessel density	The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 4 weeks	4 weeks

External Links

•   Ajou University Hospital (Eng ver.)
•   Institutional Review Board, Ajou University Hospital