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Mar. 04, 2019 |
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Mar. 29, 2024 |
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jRCTs062180038 |
Usefulness of linked color image (LCI) for colon SSA/P surveillance (LCI for SSA/P) |
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Linked color image for SSA/P (LCI for SSA/P) |
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May. 31, 2022 |
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33 |
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Group A (n=15) : Male 8 cases, Female 7 cases, Age 68.6, +/- 6.7 years old Group B (n=18) : Male 8 cases, Female 10 cases, Age 65.7, +/- 9.1 years old |
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Thirty-three patients with a history of endoscopic resection of SSA/P or untreated SSA/P were screened, and all of them were eligible. Eligible patients were randomly assigned using the envelope method, with 15 patients assigned to group A and 18 patients assigned to group B. |
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There were no adverse events during the trial period. |
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The primary endpoint of the study is additional SSA/P detection rate for Group A and Group B. In the second detection, 1 SSA/P was detected in Group A and 9 SSA/Ps were detected in Group B. Additional detection rate was 8.3% (1/12) in Group A and 45.0% (9/20) in Group B. Additional SSA/P detection rate was significantly higher in Group B (p=0.004). Additional adenoma detection rate was significantly higher in Group B than in Group A (64.3% in Group B vs 7.7% in Group A; p=0.004). There was no significant difference in additional hyperplastic polyp detection rate between Group A and Group B (7.1% in Group A vs 50.0% in Group B; p=0.242). In Group B, 11 SSA/Ps were detected in first inspection by WLI, and 9 SSA/Ps were detected in second inspection by LCI. The location of SSA/P detected by WLI was 4 lesions in cecum (36.4%), 2 lesions in ascending colon (18.2%), and 5 lesions in transverse colon (45.5%). The location of SSA/P detected by LCI was were 1 lesion in cecum (11.1%), 4 lesion in ascending colon (44.4%), and 4 lesions in the transverse colon (44.4%). There was no significant difference. Regarding the size, 2 lesions (18.2%) were 10 mm or more, 9 lesions (81.8%) were less than 10 mm in WLI, and 2 lesions (22.2%) were 10 mm or more, and 7 lesions (77.8%) were less than 10 mm in LCI. There was no significant difference. Regarding the color, 4 lesions (36.4%) was fading and 7 lesions (63.6%) was the same color in WLI, and 2 lesions (22.2%) was fading and 7 lesions (77.8%) was the same color LCI. There was no difference. |
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RCT data demonstrated that the rate of additional detection of SSA/P with LCI mode was significantly higher than white light. LCI mode is superior to white light for detection of SSA/P. |
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Mar. 01, 2024 |
No |
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N/A |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs062180038 |
Takayama Tetsuji |
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Tokushima University Hospital |
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18-15, Kuramoto-cho, Tokushima city, Tokushima |
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+81-88-633-7124 |
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takayama@tokushima-u.ac.jp |
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Kagemoto Kaizo |
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Tokushima University Hospital |
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18-15, Kuramoto-cho, Tokushima city, Tokushima |
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+81-88-633-7124 |
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kagemoto.kaizo@tokushima-u.ac.jp |
Complete |
Mar. 01, 2019 |
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| May. 07, 2019 | ||
| 51 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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uncontrolled control |
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crossover assignment |
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diagnostic purpose |
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Patients with SSA/P |
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Patients who underwent colectomy, Antiplatelet medicine |
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| 20age old over | ||
| No limit | ||
Both |
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SSA/P |
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Colonoscopy |
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Serrated polyp |
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Colonoscopy |
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Detection rate of SSA/P |
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Detection rate of other colon polyps |
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| FUJIFILM Corporation | |
| Not applicable |
| Clinical Research Review Board of Tokushima University | |
| 2-50-1, Kuramoto-cho, Tokushima city, Tokushima | |
+81-88-633-7958 |
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| brinshoshienk@tokushima-u.ac.jp | |
| Approval | |
Dec. 11, 2018 |
| なし | |
| Naruto Hospital |
none |