UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037591 |
|---|---|
| Receipt number | R000042856 |
| Scientific Title | A single-center retrospective study regarding the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in patients with acute hemorrhage of the lower digestive tract |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2023/02/05 11:57:13 |
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Basic information
Public title
A single-center retrospective study regarding the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in patients with acute hemorrhage of the lower digestive tract
Acronym
A single-center retrospective study regarding the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in patients with acute hemorrhage of the lower digestive tract
Scientific Title
A single-center retrospective study regarding the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in patients with acute hemorrhage of the lower digestive tract
Scientific Title:Acronym
A single-center retrospective study regarding the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in patients with acute hemorrhage of the lower digestive tract
Region
| Japan |
Condition
Condition
colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether there is a significant decrease in the hemostasis rate after emergency lower gastrointestinal endoscopy following contrast-enhanced CT in comparison with the elective contrast-enhanced CT group in patients with acute hemorrhage of the lower digestive tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of patients in whom the source of hemorrhage was identified using contrast-enhanced CT of the lower digestive tract, rate of patients in whom the source of hemorrhage was identified using emergency lower gastrointestinal endoscopy, and rebleeding rate within 7 days after the initial onset.
Key secondary outcomes
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
| 37 | years-old | <= |
Age-upper limit
| 96 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with hemorrhage of the lower digestive tract requiring admission, those who underwent contrast-enhanced CT at the Emergency Outpatient Unit or during admission, followed by detailed examination for gastrointestinal hemorrhage, and those aged more than 20 years on admission.
Key exclusion criteria
patients with hematemesis, black vomit, or tarry stool, those who underwent upper gastrointestinal endoscopy and were diagnosed with hemorrhage of the upper digestive tract, and those who underwent IVR or abdominal surgery during admission.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Kamoshida |
Organization
Hitachi General Hospital
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
TEL
0294-23-1111
toshiro.kamoshida.fu@hitachi.com
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Kamoshida |
Organization
Hitachi General Hospital
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
TEL
0294-23-1111
Homepage URL
toshiro.kamoshida.fu@hitachi.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi General 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
Hitachi General Hospital
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
Tel
0294-23-1111
toshiro.kamoshida.fu@hitachi.com
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
| 2019 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040177/
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040177/
Number of participants that the trial has enrolled
317
Results
SRH were identified in 35.0% (35/100) of the urgent CT cases and 7.3% (6/82) of the elective CT cases (P < 0.01). Among all patients with extravasation-positive images on CT, SRH was identified in 31 out of 47 patients (66.0%) in the urgent CT group and 4 out of 20 patients (20.0%) in the elective CT group (P < 0.01). Furthermore, rates of rebleeding within 30 d were significantly improved in the urgent CT and extravasation-positive cases (P < 0.05).
Results date posted
| 2023 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Colonoscopy within 24 h of hospital admission for colonic diverticular bleeding (CDB) is recommended. However, little is known about rates of rebleeding within 30 d. We posited that a group of patients who underwent contrast-enhanced computed tomography (CT) within 4 h of the last hematochezia and colonoscopy within 24 h would experience fewer incidences of rebleeding.
Participant flow
Data from 182 patients with CDB who underwent contrast-enhanced CT and colonoscopy between January 2011 and December 2018 at the study site were retrospectively reviewed. Patients were divided into groups based on the timing of the CT imaging, within or at 4 h were defined as urgent CTs (n = 100) and those performed after 4 h were defined as elective CTs (n = 82). Main outcomes included rebleeding within 30 d and the identification of stigmata of recent hemorrhage (SRH) (i.e., active bleeding, non-bleeding visible vessels, or adherent clots).
Adverse events
N/A
Outcome measures
The rate of extravasation-positive images, SRH, rebleeding within 30 day
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Approval by the Ethics Review Board
The principal investigator will submit the protocol of this study to the Ethics Review Board of this institution for inspection, and obtain approval on the study execution from the director of this institution.
(2) Study type/design
A single-center, retrospective, comparative study.
(3) Study period
One year.
(4) Storage of samples from human bodies and information to be used for research
The information obtained in this study will be centrally stored on a security-assured personal computer.
The data will be anonymized, and used for this study alone. As a rule, the principal investigator of this institution must store the data on a password-locked personal computer and paper materials in a key-locked locker in this institution.
As a rule, the data input to a personal computer should be stored for 5 years or 3 years after the publication of an article (the longer period should be chosen).
Management information
Registered date
| 2019 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042856
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