Clinical trial NCT02926716: NBI for Identifying Resection Margin Status in Gastric Cancer
Official title: Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Stomach neoplasm
Endoscopy
Narrow band imaging
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient who is diagnosed as early staged gastric cancer preoperatively

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy for identifying the status of resection margin
timeFrame: 2 weeks
Secondary outcomes:
measure: Tumor size
timeFrame: 2 weeks
measure: Microvessel density
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Suwan
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi-do
Study officials:
References:
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. Epub 2014 May 8.
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.
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. Epub 2013 Aug 7.
citation: 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.