Back to resultsUsefulness of Near-focus With Narrow-band Imaging
Primary Purpose
Gastric Tumors
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Near focus with narrow band imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Tumors focused on measuring near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy
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
Sites / Locations
- Cheonan Hospital, Soonchunhyang University College of Medicine
- Korea University Medical Center
- Inha University School of Medicine
- Pusan National University School of Medicine
- Kyung Hee University Hospital
- Severance Hospital, Yonsei University College of Medicine
- Soonchunhyang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Near focus with narrow band imaging
Indigo carmin
Arm Description
Near focus with narrow band imaging is used for marking the tumor margin.
After indigo carmine was sprayed over the lesion, marking is performed.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02661945
First Posted
January 20, 2016
Last Updated
May 31, 2019
Sponsor
Kyunghee University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02661945
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Tumors
Keywords
near focus with narrow band imaging, tumor margin, indigocarmine chromoendoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Near focus with narrow band imaging
Arm Type
Experimental
Arm Description
Near focus with narrow band imaging is used for marking the tumor margin.
Arm Title
Indigo carmin
Arm Type
No Intervention
Arm Description
After indigo carmine was sprayed over the lesion, marking is performed.
Intervention Type
Device
Intervention Name(s)
Near focus with narrow band imaging
Primary Outcome Measure Information:
Title
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)
Description
Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm
Time Frame
1 week after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cheonan Hospital, Soonchunhyang University College of Medicine
City
Cheonan
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Name
Korea University Medical Center
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Inha University School of Medicine
City
Incheon
Country
Korea, Republic of
Facility Name
Pusan National University School of Medicine
City
Pusan
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22136775
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.
Results Reference
background
PubMed Identifier
20880172
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.
Results Reference
result
PubMed Identifier
32433790
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.
Results Reference
derived
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Usefulness of Near-focus With Narrow-band Imaging
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