UMIN-CTR Clinical Trial

Public title

Utility of capsule endoscopy for acute lower gastrointestinal bleeding; a prospective observational study

Acronym

Capsule endoscopy for acute lower gastrointestinal bleeding; a prospective observational study

Scientific Title

Utility of capsule endoscopy for acute lower gastrointestinal bleeding; a prospective observational study

Scientific Title:Acronym

Capsule endoscopy for acute lower gastrointestinal bleeding; a prospective observational study

Region

Japan

Condition

Acute lower gastrointestinal bleeding

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate how capsule endoscopy is useful for diagnosis and management of acute lower gastrointestinal bleeding.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The diagnostic yield of capsule endoscopy

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
1.Adults aged>=20 years presenting
moderate to severe hematochezia or melena
within 24 h on arrival, defined as (i) more than 3 bloody bowel movements within 8 h; (ii) hemorrhagic shock; or (iii) requiring transfusion.
2.negative colonoscopy results
3.All patients were able to provide informed consent.

Key exclusion criteria

1.Patients with hematemesis, black vomiting, or melena
2.Upper gastrointestinal bleeding patients who diagnosed by nasogastric tube or upper endoscopy
3.Preparation for colonoscopy was poor
4.Patients with suspected perforation, peritonitis, or intestinal obstruction
5.Crohn diseases patients
6.Patients with swallowing disorders
7.Patients with an installed pacemaker or other electromedical device
8.Patients who could not perform surgery according to adverse general condition when complication occurred
9.Patients who were diagnosed as active upper gastrointestinal bleeding within 10 days
10.Patients who received abdominal surgery within 10 days
11.Patients with end stage malignant disease
12.Patients with severe cardiac failure
13.Patients with severe respiratory failure
14.Pregnant patients

Target sample size

60

Name of lead principal investigator

1st name	Nobumi
Middle name
Last name	Suzuki

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

yamada-a@umin.ac.jp

Name of contact person

1st name	Tomonori
Middle name
Last name	Aoki

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

yamada-a@umin.ac.jp

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

23

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35772398/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35772398/

Number of participants that the trial has enrolled

60

Results

https://pubmed.ncbi.nlm.nih.gov/35772398/

Results date posted

2023

Year

04

Month

17

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

https://pubmed.ncbi.nlm.nih.gov/35772398/

Participant flow

https://pubmed.ncbi.nlm.nih.gov/35772398/

Adverse events

https://pubmed.ncbi.nlm.nih.gov/35772398/

Outcome measures

https://pubmed.ncbi.nlm.nih.gov/35772398/

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

03

Month

13

Day

Date of IRB

2017

Year

03

Month

23

Day

Anticipated trial start date

2017

Year

03

Month

23

Day

Last follow-up date

2021

Year

11

Month

24

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective study

Registered date

2017

Year

03

Month

23

Day

Last modified on

2023

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030631