NBI for Identifying Resection Margin Status in Gastric Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Accuracy for identifying the status of resection margin [2 weeks]
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
Secondary Outcome Measures
- Tumor size [2 weeks]
The tumor size assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
- Microvessel density [4 weeks]
The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 4 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient from over 20 to under 90 years
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The patient who is diagnosed as gastric cancer clinically by endoscopy or computed tomography
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The patient who is informed and consent about the purpose and contents of this study prior to the participation in this study
Exclusion Criteria:
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The patient who shows far advanced gastric cancer preoperatively or intraoperatively
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The patient with previous medical history of other treatment for gastric caner such as endoscopic resection, chemotherapy, radiation, immunotherapy, and so on
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ajou University School of Medicine | Suwan | Gyeonggi-do | Korea, Republic of | 443-749 |
Sponsors and Collaborators
- Ajou University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- AJIRB-MED-SMP-15-10