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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name