NBI for Identifying Resection Margin Status in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02926716|
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : February 17, 2017
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|
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 Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer|
|Actual Study Start Date :||December 14, 2015|
|Actual Primary Completion Date :||December 29, 2016|
|Actual Study Completion Date :||December 29, 2016|
- 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
- Tumor size [ Time Frame: 2 weeks ]The tumor size assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks
- Microvessel density [ Time Frame: 4 weeks ]The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 4 weeks
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926716
|Korea, Republic of|
|Ajou University School of Medicine|
|Suwan, Gyeonggi-do, Korea, Republic of, 443-749|