Clinical trial NCT02661945: Usefulness of Near-focus With Narrow-band Imaging
Official title: Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Tumors
Keywords: near focus with narrow band imaging
tumor margin
indigocarmine chromoendoscopy
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 444
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* fail to en bloc resection

Primary outcomes:
measure: Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)
timeFrame: 1 week after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Cheonan Hospital, Soonchunhyang University College of Medicine
state: Chungcheongnam-do
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
state: Seongbuk-gu
city: Incheon
country: Korea, Republic of
facility: Inha University School of Medicine
city: Pusan
country: Korea, Republic of
facility: Pusan National University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
References:
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.
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: Kim JW, Jung Y, Jang JY, Kim GH, Bang BW, Park JC, Choi HS, Cho JH; Research Group for Endoscopic Instruments and Stents of Korean Society of Gastrointestinal Endoscopy. Narrowband imaging with near-focus magnification for discriminating the gastric tumor margin before endoscopic resection: A prospective randomized multicenter trial. J Gastroenterol Hepatol. 2020 Nov;35(11):1930-1937. doi: 10.1111/jgh.15109. Epub 2020 Jun 16.