UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036734 |
|---|---|
| Receipt number | R000041830 |
| Scientific Title | A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection) |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2024/05/17 10:48:53 |
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Basic information
Public title
A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)
Acronym
A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)
Scientific Title
A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)
Scientific Title:Acronym
A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of delayed bleeding after prophylactic clip closure
Key secondary outcomes
The severity of delayed bleeding
Timing of delayed bleeding
The rate of thromboembolism
Closure time, The number of clips, The rate of lesions which cannot be closed
The incidence rate of PECS
Duration of hospitalization
The rate of delayed perforation
The rate of all adverse events
The rate of adverse events associated with ESD
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Prophylactic clip closure after colorectal ESD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with colorectal neoplasms considered an indication for colorectal ESD.
2)Lesions not larger than 50mm in diameter.
3)Allow multiple ESD and /or endoscopic resection other than ESD scheduled at the same time
4)Age 20 or older at registration.
5)Performance Status (ECOG) is 0, 1 or 2.
6)Receiving anticoagulant therapy.
7)Preserved major organs functions (bone marrow, liver, kidney, lung etc.).
8)Written informed consent from the patient himself.
Key exclusion criteria
1)Lesions extending to the anal canal or ileocecal valve.
2)Have schedules to receive another endoscopic resection for colorectal neoplasms within 28 days after this ESD.
3)Have schedules to receive chemotherapy, radiation therapy or surgery within 28 days after this ESD.
4)Judged that registration or participation in this study is difficult due to a psychiatric disorder.
5)allergy to metal.
6)Otherwise determined by investigators to be unsuitable for participation in this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideharu |
| Middle name | |
| Last name | Ogiyama |
Organization
Ikeda Municipal Hospital
Division name
Department of Gastroenterology
Zip code
563-8510
Address
3-1-18 Jyonan, Ikeda, Osaka, Japan
TEL
072-751-2881
Homepage URL
hideharu-ogiyama@hosp.ikeda.osaka.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
Osaka University Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6879-5111
rinri@hp-crc.med.osaka-u.ac.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
| 2019 | Year | 07 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041830
