UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033989 |
|---|---|
| Receipt number | R000038755 |
| Scientific Title | Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2024/03/06 09:25:32 |
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Basic information
Public title
Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Acronym
Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Scientific Title
Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Scientific Title:Acronym
Efficacy of conventional endoscopy using non-extension sign for optical diagnosis of colorectal epitherial neoplasms
Region
| Japan |
Condition
Condition
colorectal epithelial neoplasm
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the non-extension sign in assessing the optical diagnosis of colorectal epitherial neoplasm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each modality in diagnosing SM-deep cancer in adenoma and early colorectal caner with non-extension sign as an index for the diagnosis of SM-deep cancer.
Key secondary outcomes
1.Comparing the accuracy of conventional endoscopy using non-extension sign, magnifying narrow-band imaging, and magnifying chromoendoscopy for optical diagnosis.
2.Others, evaluate all the various result.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients performed endoscopic or surgical resection for colorectal epithelial neoplasm (adenoma and early colorectal cancer)
2. ECOG-performance status is 0 or 1 point.
3. Over 20 years old
4. Written informed consent
Key exclusion criteria
1. Pedunculated-type lesion
2. Serrated lesion
3. Lesions that are difficult to assess because observation conditions are poor.
4. Impossible pathological evaluation
5. Cases are inflammatory bowel disease, colitis-associated colorectal cancer, advanced cancer, after colon resection, familial adenomatous polyposis.
6. Patients with serious complication.
7. Patients who were judged inappropriate by their physicians.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Hisabe |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Zokumyoin Chikushino-city, Fukuoka, Japan
TEL
092-921-1011
hisabe@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuhisa Yasaka |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Zokumyoin Chikushino-city, Fukuoka, Japan
TEL
092-921-1011
Homepage URL
tatsuhisa1023@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学筑紫病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non-extension sign;
Indigo carmine is sprayed and the colonic wall is strongly extended by endoscopic insufflation of a large volume of air. The area of intramucosal cancer become flattened and extended. On the other hand, the area of SM-deep cancer can be seen as an elevation of the surrounding mucusa due to localized thickening and hardening.
We observe the lesion from the lesion from the front and oblique or tangential directions. Lesions are assessed as positive for non-extension sign if any of the following 3 findings are seen.
1. Rigidity against a background circular arc
2. Trapezoid elevation
3. Converging mucosal folds
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038755
