Usefulness of Near-focus With Narrow-band Imaging

Gastric Tumors Clinical Trial

Official title:

Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661945
• Other study ID #: NFNBI
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: May 2019
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)

Exclusion Criteria:

• fail to en bloc resection

Related Conditions & MeSH terms

• Gastric Tumors
• Stomach Neoplasms

Intervention

Device:
• Near focus with narrow band imaging

Locations

Country	Name	City	State
Korea, Republic of	Cheonan Hospital, Soonchunhyang University College of Medicine	Cheonan	Chungcheongnam-do
Korea, Republic of	Inha University School of Medicine	Incheon
Korea, Republic of	Pusan National University School of Medicine	Pusan
Korea, Republic of	Korea University Medical Center	Seoul	Seongbuk-gu
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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: 10.1 — View Citation

Nagahama T, Yao K, Maki S, Yasaka M, Takaki Y, Matsui T, Tanabe H, Iwashita A, Ota A. Usefulness of magnifying endoscopy with narrow-band imaging for determining the horizontal extent of early gastric cancer when there is an unclear margin by chromoendoscopy (with video). Gastrointest Endosc. 2011 Dec;74(6):1259-67. doi: 10.1016/j.gie.2011.09.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)	Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm	1 week after procedure