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Japanese

Mar. 04, 2019

Mar. 29, 2024

jRCTs062180038

Usefulness of linked color image (LCI) for colon SSA/P surveillance (LCI for SSA/P)

Linked color image for SSA/P (LCI for SSA/P)

May. 31, 2022

33

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

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.

There were no adverse events during the trial period.

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.

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.

Mar. 01, 2024

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs062180038

Takayama Tetsuji

Tokushima University Hospital

18-15, Kuramoto-cho, Tokushima city, Tokushima

+81-88-633-7124

takayama@tokushima-u.ac.jp

Kagemoto Kaizo

Tokushima University Hospital

18-15, Kuramoto-cho, Tokushima city, Tokushima

+81-88-633-7124

kagemoto.kaizo@tokushima-u.ac.jp

Complete

Mar. 01, 2019

May. 07, 2019
51

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

diagnostic purpose

Patients with SSA/P

Patients who underwent colectomy, Antiplatelet medicine

20age old over
No limit

Both

SSA/P

Colonoscopy

Serrated polyp

Colonoscopy

Detection rate of SSA/P

Detection rate of other colon polyps

FUJIFILM Corporation
Not applicable
Clinical Research Review Board of Tokushima University
2-50-1, Kuramoto-cho, Tokushima city, Tokushima

+81-88-633-7958

brinshoshienk@tokushima-u.ac.jp
Approval

Dec. 11, 2018

なし
Naruto Hospital

none

History of Changes

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1 Mar. 04, 2019 Detail