UMIN-CTR Clinical Trial

Public title

Beneficial Effects of Combining Computed Tomography Enteroclysis/Enterography with Capsule Endoscopy for Screening Tumor Lesions in the Small Intestine

Acronym

Beneficial Effects of Combining CTE with CE for Screening Tumor Lesions in the Small Intestine

Scientific Title

Beneficial Effects of Combining Computed Tomography Enteroclysis/Enterography with Capsule Endoscopy for Screening Tumor Lesions in the Small Intestine

Scientific Title:Acronym

Beneficial Effects of Combining CTE with CE for Screening Tumor Lesions in the Small Intestine

Region

Japan

Condition

Tumor lesions in the small intestine

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the efficacy of using computed tomography enteroclysis/enterography (CTE), capsule endoscopy (CE), and CTE with CE for diagnosing tumor lesions in the small intestine.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Diagnostic yield of small bowel tumors at the time of capsule endoscopy and CT enteroclysis / enterography, and it was a combination of both.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

21

years-old

<=

Age-upper limit

87

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)It does not matter age, gender.
2)It does not matter hospitalization, outpatient.
3) After underwent CT enteroclysis / enterography and capsule endoscopy, was elected a case that could follow-up for more than 3 months.

Key exclusion criteria

After underwent capsule endoscopy and CT enteroclysis / enterography, cases that could not be observation for more than 3 months.

Target sample size

98

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Hashimoto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

+81-836-22-2241

Email

has-333@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Hashimoto

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

+81-836-22-2241

Homepage URL

Email

has-333@yamaguchi-u.ac.jp

Institute

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

山口大学医学部附属病院(山口県)

Date of disclosure of the study information

2015

Year

01

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2014

Year

09

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A definitive diagnosis of the tumor lesions in the small intestine was determined on the basis of findings from histopathological tests conducted on resected or biopsy specimens collected from Baloon endscopy or surgery.
For patients who did not undergo Baloon endscopy or surgery, the final diagnosis was determined on the basis of clinical and imaging findings.
The criteria for a negative tumor lesions in the small intestines were as follows: 1) no tumor was detected by CE or CTE; 2) the presence of the tumor lesions was negative in Baloon endscopy and surgical findings; and 3) the symptoms believed to be due to neoplastic lesions were absent for more than 3 months after the tests.

Registered date

2015

Year

01

Month

07

Day

Last modified on

2015

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017781