UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063378 |
|---|---|
| Receipt number | R000071632 |
| Scientific Title | The Detectability of Colorectal Adenomas of Narrow Band Imaging plus Texture and Color Enhancement Imaging mode: A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/23 |
| Last modified on | 2026/10/22 20:38:50 |
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Basic information
Public title
The Detectability of Colorectal Adenomas of Narrow Band Imaging plus Texture and Color Enhancement Imaging mode: A Prospective Randomized Controlled Trial
Acronym
NEXT trial
Scientific Title
The Detectability of Colorectal Adenomas of Narrow Band Imaging plus Texture and Color Enhancement Imaging mode: A Prospective Randomized Controlled Trial
Scientific Title:Acronym
NEXT trial
Region
| Japan |
Condition
Condition
Colorectal polyp, Colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the use of Narrow Band Imaging plus Texture and Color Enhancement Imaging (NBI+TXI) mode improves the adenoma detection rate (ADR) compared with White Light Imaging (WLI) during screening or surveillance colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma detection rate (ADR)
Key secondary outcomes
1. Adenoma per colonoscopy (APC)
2. Advanced adenoma detection rate (AADR)
3. SSL detection rate (SSLDR)
4. SSL per colonoscopy (SSLPC)
5. Proximal serrated lesion detection rate (PRSLDR)
6. Proximal serrated lesion per colonoscopy (PRSLPC)
7. Polyp detection rate (PDR)
8. Polyp per colonoscopy (PPC)
9. Procedure time (Cecal intubation time and withdrawal time)
10. Adverse event rate
11. Boston Bowel Preparation Score (BBPS)
12. Aronchick scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NBI+TXI group: A single whole-colorectal observation using NBI+TXI (Narrow Band Imaging plus Texture and Color Enhancement Imaging) mode during endoscope withdrawal from the cecum to the rectum on the day of the colonoscopy.
Interventions/Control_2
WLI group: A single whole-colorectal observation using conventional WLI (White Light Imaging) during endoscope withdrawal from the cecum to the rectum on the day of the colonoscopy.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled for total colonoscopy for screening (including positive fecal occult blood test and investigation of abdominal symptoms) or post-polypectomy surveillance.
2. Patients aged 40 to 80 years at the time of informed consent.
3. Patients who have received sufficient explanation about the study and have voluntarily provided written informed consent.
Key exclusion criteria
1. Patients with a history of colorectal resection (excluding appendectomy).
2. Patients with a history of inflammatory bowel disease.
3. Patients with a history of colorectal polyposis.
4. Patients with known existing colorectal polyps.
5. Pregnant or breastfeeding women.
6. Patients who have previously participated in this study.
7. Patients participating in other endoscopy-related interventional studies.
8. Patients deemed inappropriate for study participation by the investigator due to underlying diseases or other reasons.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University
Division name
Department of Gastroenterology, Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5537
oka4683@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kishida |
Organization
Hiroshima University
Division name
Department of Community-Based Medical System, Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5538
Homepage URL
kishida1@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Shiro Oka
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1946
iryo-sinsa@office.hiroshima-u.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
広島大学病院（広島県）、県立広島病院（広島県）、広島市立北部医療センター安佐市民病院（広島県）、JA広島総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071632
