UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050488 |
|---|---|
| Receipt number | R000057511 |
| Scientific Title | Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study. |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2023/03/04 12:24:01 |
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Basic information
Public title
Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.
Acronym
Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.
Scientific Title
Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.
Scientific Title:Acronym
Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.
Region
| Japan |
Condition
Condition
Early stage colorectal cancer, Early stage gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
PureStat is a peptide-derived absorbable haemostatic agent used to reduce the number of cauterisations with haemostatic forceps for leakage bleeding in artificial ulcers following endoscopic submucosal dissection (ESD) and other gastrointestinal endoscopic procedures. The aim of the study was to determine whether the use of PureStat on the ulcer bed following colorectal and gastric ESD in patients taking antiplatelet or anticoagulant medication can reduce the incidence of post-operative complications such as posterior bleeding.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of posterior bleeding after endoscopic submucosal dissection.
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
(1)Patients with a preoperative colonoscopy and endoscopic or histopathological diagnosis of early colorectal cancer with a predicted depth of Tis(intramucosal cancer) to T1a and who will undergo ESD.
(2)Patients diagnosed with early gastric cancer or gastric adenoma who are considered eligible for ESD based on size, histological type and depth, and who will undergo ESD(eligibility is determined based on the ESD/EMR guidelines for gastric cancer, 2nd edition).
(3)Patients regularly taking antiplatelet or anticoagulant medication.
(4)Patients for whom informed written consent has been obtained.
Key exclusion criteria
(1)Patients with a history of hypersensitivity to peptide or protein preparations.
(2) Patients who are considered by the investigator to be unsuitable for participation in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinari |
| Middle name | |
| Last name | Takao |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
0338232101
globes.and.maps.1228@gmail.com
Public contact
Name of contact person
| 1st name | Akinari |
| Middle name | |
| Last name | Takao |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
0338232101
Homepage URL
globes.and.maps.1228@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome 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
Ethics Review Committee, Tokyo Metropolitan Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
Tel
0338232101
km_rinri@tmhp.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 | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the incidence of adverse events, such as post-bleeding, following the application of peptide-derived absorbable haemostatic agents to artificial ulcers immediately following endoscopic treatment of early-stage colorectal cancer or early-stage gastric cancer.
Management information
Registered date
| 2023 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057511
