Unique ID issued by UMIN | UMIN000023863 |
---|---|
Receipt number | R000026838 |
Scientific Title | LCI- Further Improving Neoplasm Detection in upper GI |
Date of disclosure of the study information | 2016/09/30 |
Last modified on | 2020/09/03 18:18:48 |
LCI- Further Improving Neoplasm Detection in upper GI
LCI-FIND TRIAL
LCI- Further Improving Neoplasm Detection in upper GI
LCI-FIND TRIAL
Japan |
neoplasm detection in upper GI
Gastroenterology |
Malignancy
NO
To investigate the usefulness of linked color imaging detecting the neoplasm of upper GI in the gastrointestinal cancer patients
Efficacy
Confirmatory
Pragmatic
Not applicable
The primary endpoint was the percentage of patients diagnosed as having a
neoplastic lesion in the pharynx, esophagus, or stomach using each of WLI
and LCI in the first examination.
The secondary endpoints were the percentages of patients diagnosed,using WLI and LCI, as having a neoplastic lesion stratified by location,size or morphology of the lesions or diagnostic confirmation in the first examination as well as the percentage of patients diagnosed, using WLI and
LCI,as having neoplastic lesions or adverse events in the second examination.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Diagnosis
Device,equipment |
Endoscopic examination with linlked color imaging before conventional white light imaging observation
Endoscopic examination with linked color imaging after conventional white light imaging observation
20 | years-old | <= |
89 | years-old | >= |
Male and Female
Patients who plan to undergo upper gastrointestinal endoscopy and who meet one of following
1) Patients who have history of gastrointestinal cancer (which included oral cavity, larynx, pharynx)
2) Patients whose endoscopy is performed for the present gastrointestinal cancer (which included oral cavity, larynx,pharynx)
3) Patients who have history of chemotherapy or radiotherapy
4)Patients who have history of surgical esophageal or gastric resection.
1)Patients taking medicines which cause the trouble in obtaining a biopsy tissue
2)Patients who have trouble in undergoing endoscopy
3)Patients with dementia or with disctuebance of consciousness
4)Patients has determined that inappropriate by principal investigator
1500
1st name | Mototsugu |
Middle name | |
Last name | Kato |
National Hospital Organization Hakodate National Hospital
gastroenterology
0418512
kawaharacho 18-16, Hakodate, Hokkaido
0138-51-6281
mkato1957@gmail.com
1st name | Motitsugu |
Middle name | |
Last name | Kato |
National Hospital Organization Hakodate National Hospital
gastroenterology
0418512
kawaharacho 18-16, Hakodate, Hokkaido
0138-51-6281
mkato1957@gmail.com
National Hospital Organization Hakodate National Hospital
National Hospital Organization Hakodate National Hospital
Self funding
Department of esophageal surgery, Tokyo Medical and Dental University
Yushima1-5-45, Bunkyoku, Tokyo ,Japan
0358035254
kawada.srg1@tmd.ac.jp
NO
国立病院機構函館病院(北海道)
小樽掖済会病院(北海道)
東京医科歯科大学医学部附属病院(東京都)
朝日大学歯学部附属村上記念病院(岐阜県)
京都府立医大病院(京都府)
京都府立医大北部医療センター(京都府)
四国がんセンター(愛媛県)
岡山大学病院(岡山県)
川崎医科大学病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
大分大学医学部附属病院(大分県)
北海道大学医学部附属病院(北海道)
徳島大学医学部附属病院(徳島県)
鹿児島大学医学部附属病院(鹿児島県)
佐賀大学医学部附属病院(佐賀県)
東北大学医学部附属病院(宮城県)
広島大学医学部附属病院(広島県)
大阪医科大学(大阪府)
長崎大学医学部附属病院(長崎県)
2016 | Year | 09 | Month | 30 | Day |
Unpublished
1508
Delay expected |
the paper was now revised
Main results already published
2016 | Year | 08 | Month | 19 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 11 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2019 | Year | 03 | Month | 11 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 08 | Month | 31 | Day |
2020 | Year | 09 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026838
Research Plan | |
---|---|
Registered date | File name |
2018/07/25 | LCI Study研究実施計画書第11版.pdf |
Research case data specifications | |
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Registered date | File name |
2018/10/19 | LCI-FIND CRF.pdf |
Research case data | |
---|---|
Registered date | File name |
2019/03/13 | 写真判定会議 討論結果データ解析用(20190313).xlsx |