UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053802 |
|---|---|
| Receipt number | R000061408 |
| Scientific Title | The evaluation of the efficacy of clipping, EBL, and OTSC in endoscopic treatments for colonic diverticular bleeding |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2025/09/09 15:14:14 |
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Basic information
Public title
The evaluation of the efficacy of clipping, EBL, and OTSC in endoscopic treatments for colonic diverticular bleeding
Acronym
The evaluation of the efficacy of endoscopic treatments for colonic diverticular bleeding
Scientific Title
The evaluation of the efficacy of clipping, EBL, and OTSC in endoscopic treatments for colonic diverticular bleeding
Scientific Title:Acronym
The evaluation of the efficacy of endoscopic treatments for colonic diverticular bleeding
Region
| Japan |
Condition
Condition
colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hemostasis using clipping, EBL (Endoscopic Band Ligation), and OTSC (Over-The-Scope Clip) for colonic diverticular bleeding
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of 30-day recurrent bleeding in the comparison of clipping, EBL and OTSC.
Key secondary outcomes
Percentage of requirements for IVR
Endoscopically relevant adverse events
Requirement of red blood cell transfusion
The length of hospital stay after endoscopic treatment
risk factors for recurrent bleeding with various hemostasis methods.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old
cases diagnosed with colonic diverticular bleeding and underwent endoscopic treatment
Key exclusion criteria
The patients who are otherwise judged by the investigator to be ineligible to participate in the study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Ohashi |
Organization
Central Japan International Medical Center
Division name
Gastroenterology
Zip code
505-8510
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
TEL
0574-66-1100
yosuke-ohashi14@hotmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Ohashi |
Organization
Central Japan International Medical Center
Division name
Gastroenterology
Zip code
505-8510
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
TEL
0574-66-1100
Homepage URL
yosuke-ohashi14@hotmail.com
Sponsor or person
Institute
Central Japan International Medical Center
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
Ethics Committee of Central Japan International Medical Center
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
Tel
0574-66-1100
yosuke-ohashi14@hotmail.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
| 2024 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0016510725019145?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0016510725019145?via%3Dihub
Number of participants that the trial has enrolled
333
Results
We included 511 cases (333 patients) of CDB; 110 cases of presumptive CDB, 83 cases that received clipping, 15 cases that received IVR, 231 cases underwent EBL and 72 underwent OTSC for CDB treatment.In particular, EBL and OTSC,a total of 303 cases (247 patients) were enrolled in the study, with the EBL (231 cases) and OTSC (72 cases) groups comprising 68 cases each in the propensity score-matched cohort. As a result, OTSC showed a significantly lower early recurrent bleeding rate compared with EBL
Results date posted
| 2025 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included 511 cases (333 patients) of CDB; 110 cases of presumptive CDB, 83 cases that received clipping, 15 cases that received IVR, 231 cases underwent EBL and 72 underwent OTSC for CDB treatment.In particular, we focused on a detailed investigation of EBL and OTSC, which are highly effective endoscopic hemostatic methods.We included cases with SRH identified on endoscopy.
Participant flow
We included 511 cases (333 patients) of CDB; 110 cases of presumptive CDB, 83 cases that received clipping, 15 cases that received IVR, 231 cases underwent EBL and 72 underwent OTSC for CDB treatment.In particular, we focused on a detailed investigation of EBL and OTSC, which are highly effective endoscopic hemostatic methods.We included cases with SRH identified on endoscopy.
Adverse events
Regarding AEs, one patient (treated in right side colon) in the OTSC group had intestinal stenosis. Diverticulitis was observed in three patients (treated in the left colon in two and in the right colon in one) in the EBL group and one (treated in left side colon) in the OTSC group. One patient in the EBL group (treated in left side colon) experienced colon penetration. All AEs improved with intestinal rest after fasting and/or antibiotic treatment; no surgery or additional endoscopic treatment was required.
Outcome measures
A detailed comparative analysis of EBL and OTSC was conducted.In the EBL and OTSC groups, the rates of early recurrent bleeding were 10.8% (25/231) and 2.8% (2/72) in the unmatched cohorts and 16.2% (11/68) and 2.9% (2/68) in the matched cohorts, respectively. The rate of early recurrent bleeding was significantly lower with OTSC than with EBL in the unmatched (P=0.035) and matched cohorts (P=0.017). No significant differences in requirements of IVR, surgery, red blood cell transfusion, and AEs were found between the two groups in the unmatched and matched cohorts.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061408
