UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001473
Receipt number R000001762
Scientific Title A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.
Date of disclosure of the study information 2008/11/01
Last modified on 2010/11/02 13:14:36

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Basic information

Public title

A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.

Acronym

AFI with Transparent hood Randomized Controlled Trial (ATRACT)

Scientific Title

A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.

Scientific Title:Acronym

AFI with Transparent hood Randomized Controlled Trial (ATRACT)

Region

Japan


Condition

Condition

Colorectal neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the improvement of colorectal neoplasm detection using autofluorescence imaging colonoscopy with transparent hood.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Neoplasm detection rate

Key secondary outcomes

Total number of cancers in both group.
Total number of depressed/flat/sessile lesions. Total number of hyperplastic polyp. Total number of adenomas less than 5mm. Right-sided versus left-sided location. Total number of adenomas larger than 1cm. Total number of patients with polyps. Total number of patient with adenoma less than 5mm. Procedure time (intubation time and observation time). Adverse event.


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

4

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

White light imaging without hood group

Interventions/Control_2

White light imaging with hood group

Interventions/Control_3

Autofluorescence imaging without hood group

Interventions/Control_4

Autofluorescence imaging with hood group

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 who are undergoing screening colonoscopy for positive fecal occult blood examination, or surveillance colonoscopy after endoscopic resection for colorectal neoplasm.
2)Patients who provided written informed consent

Key exclusion criteria

1)Patients who had previously undergone major surgery.
2)Patients with open bleeding or symptoms suspected colonic stenosis.
3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm.
4)Patients who are receiving anticoaglant medication or bleeding tendency.
5)Patients with severe organ failure.
6)Patients without informed consent.
7)Patients who are regarded in-eligible by the doctor who participates in this study.

Target sample size

550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoji Takeuchi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoji Takeuchi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code


Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email

takeuti-yo@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

None

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


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



Other administrative information

Date of disclosure of the study information

2008 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.giejournal.org/current

Number of participants that the trial has enrolled


Results

Neoplasm detection rate (95% confidence interval) in the AFI+TH group was significantly higher than in the WLI alone group (1.96 [1.50-2.43] vs 1.19 [0.93-1.44]; P = .023, Tukey-Kramer multiple comparison test). Relative detection ratios (95% confidence interval) for polypoid neoplasms based on Poisson regression model were significantly increased by mounting a TH (1.69 [1.34-2.12], P < .001), and relative detection ratios for flat neoplasms were significantly increased by AFI observation (1.83 [1.24-2.71], P = .002).

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

Completed

Date of protocol fixation

2008 Year 10 Month 24 Day

Date of IRB


Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2009 Year 12 Month 01 Day

Date trial data considered complete

2010 Year 01 Month 01 Day

Date analysis concluded

2010 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 11 Month 01 Day

Last modified on

2010 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name