UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029532 |
|---|---|
| Receipt number | R000033746 |
| Scientific Title | A randomized control trial of adenoma detection in standard colonoscopy versus colonoscopy using Linked color imaging |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2021/07/27 08:10:12 |
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Basic information
Public title
A randomized control trial of adenoma detection in standard colonoscopy versus colonoscopy using Linked color imaging
Acronym
A randomized trial of adenoma detection using LCI
Scientific Title
A randomized control trial of adenoma detection in standard colonoscopy versus colonoscopy using Linked color imaging
Scientific Title:Acronym
A randomized trial of adenoma detection using LCI
Region
| Japan |
Condition
Condition
colonic adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients will undergo colonoscopy using white light imaging or LCI. Adenoma detection rate, adenoma detection number per patient, polyp number in each polyp sizes and location and insertion time and withdrawal time are examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma detection number per patient
Key secondary outcomes
adenoma detection rate, adenoma number in each sizes and locations and insertion time and withdrawal time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
white light imaging
Interventions/Control_2
LCI
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with positive fecal blood test, abdominal pain, surveillance of colonic polyp who will undergo colonoscopy
Key exclusion criteria
ileus, stenosis, fistula, post surgery for coloonic disease, active inflammatory bowel diseases, colonic diverticulitis, active colonic bleeding
alcoholsm,hyperthyroidism, severe endoclinal abnormality, severe heart disease, liver dysfunction, renal disease, hematopoietic dysorder, respiratory failure, pregnacy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
0492761667
imaedahi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
imaedahi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyorin University School of Medicine, Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1111
hirb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学病院（埼玉県）、杏林大学病院（東京都）、慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033746
Publication of results
Published
Result
URL related to results and publications
https://pubmed-ncbi-nlm-nih-gov.kras1.lib.keio.ac.jp/33973300/
Number of participants that the trial has enrolled
1000
Results
The LCI and WLI groups comprised 494 and 501 patients, respectively.The mean adenoma number per patient was significantly higher in the LCI group than in the WLI group (1.07 vs. 0.88, p=0.04).
However, the adenoma detection rate was 47.0% in the LCI group and 47.9% in the WLI group, with no significant difference.
Results date posted
| 2021 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing colonoscopy for positive fecal immunochemical tests, follow-up of colon polyps, and abdominal symptoms
Participant flow
Patients at three institutions were randomly assigned to the LCI or WLI groups.
Adverse events
no
Outcome measures
mean adenoma number per patient, adenoma detection rate, cecal insertion time, withdrawal time, mean adenoma number per location, and adenoma size
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033746
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