UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053065 |
|---|---|
| Receipt number | R000060549 |
| Scientific Title | Evaluation of Efficacy and Safety of Endoscopic Hemostasis with PuraStat in Colonic Diverticular Bleeding |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2024/12/11 11:13:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Efficacy and Safety of Endoscopic Hemostasis with PuraStat in Colonic Diverticular Bleeding
Acronym
Hemostasis with PuraStat in diverticular bleeding
Scientific Title
Evaluation of Efficacy and Safety of Endoscopic Hemostasis with PuraStat in Colonic Diverticular Bleeding
Scientific Title:Acronym
Hemostasis with PuraStat in diverticular bleeding
Region
| Japan |
Condition
Condition
colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform hemostasis (monotherapy or combined therapy with EBL (Endoscopic Band Ligation) and Clipping) with PuraStat in patients with colonic diverticular bleeding in need of hemostasis, and to collect data on outcomes such as rebleeding rate and data on complications, and to retrospectively evaluate the efficacy and safety of this treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rebleeding rate within 30 days after endoscopic hemostasis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Endoscopic hemostasis with PureStat for colonic diverticular bleeding
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colonic diverticular bleeding treated with endoscopic hemostasis using PuraStat
Key exclusion criteria
Patients with colonic diverticular bleeding treated with endoscopic hemostasis without Purastat
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954-43-1120
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954-43-1120
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
National Hospital Organization Ureshino Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Ureshino Medical Center
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
the Ethics Review Committee of the National Hospital Organization Ureshino Medical Center
Address
4279-3 Shimojyukukou, Ureshino city, Saga
Tel
0954-43-1120
honjo.yoko.vd@mail.hosp.go.jp
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
| 2023 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.gie.2024.11.006
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.gie.2024.11.006
Number of participants that the trial has enrolled
25
Results
PuraStat was used in 25 patients with colonic diverticular bleeding. The success rates were comparable between the PuraStat using group and the PuraStat non-using group (100% vs. 96.4%, P=1.000). The rate of rebleeding within 30 days was significantly lower in the PuraStat using group than PuraStat non-using group (4.0% vs. 20.9%, P=0.047).
Results date posted
| 2024 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PuraStat (3-D Matrix, Tokyo, Japan) is an absorbent localized hemostatic agent that utilizes self-assembling peptide technology. In this multicenter pilot study, we evaluated the efficacy and safety of endoscopic hemostasis using PuraStat in patients with colonic diverticular bleeding (CDB).
Participant flow
This study involved patients who had CDB with stigmata of recent hemorrhage (SRH) and underwent endoscopic hemostasis with PuraStat monotherapy or combination therapy comprising PuraStat with endoscopic band ligation (EBL) or clipping (Group A). Treatment outcomes and adverse events were assessed and compared with those of a previous cohort who underwent endoscopic hemostasis without PuraStat for CDB with SRH (Group B).
Adverse events
The primary outcome was that the rate of rebleeding within 30 days was significantly lower in Group A than in Group B (4.0% vs. 20.9%, respectively; P=0.047). The mean time to rebleeding was 3 days in Group A and 2.7 days in Group B. No difference was found in the rates of perforation and 30-day mortality between the two groups.
Outcome measures
The primary endpoint was the rebleeding rate within 30 days after hemostasis, and the secondary endpoints were hemostatic success rate, adverse events and mortality within 30 days. In addition, factors associated with the reduction of rebleeding were subsequently investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060549
