UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038049 |
|---|---|
| Receipt number | R000043371 |
| Scientific Title | Prospective study to analyze the efficacy of new electrocoagulation system (maXium) for preventing post-ESD Coagulation syndrome |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2022/03/21 10:13:14 |
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Basic information
Public title
New electrocoagulation system for preventing post-ESD Coagulation syndrome
Acronym
NewPEC trial
Scientific Title
Prospective study to analyze the efficacy of new electrocoagulation system (maXium) for preventing post-ESD Coagulation syndrome
Scientific Title:Acronym
NewPEC trial
Region
| Japan |
Condition
Condition
colorectal adenoma, early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy of colorectal ESD with new electrocoagulation system (maXium) for preventing PECS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Frequency of PECS
Key secondary outcomes
PECS frequency according to type and tumor location; The rate of delayed perforation, delayed bleeding and other complications;
Treatment time of ESD; En bloc resection rate; Elucidation for clinical features of PECS
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD
2. Age from 20 to 85 years old
3. Agreement with signed informed consent
Key exclusion criteria
1. Tumor size > 5cm
2. Cutting line will be into appendix, ileo-cecal valve or anus
3. Severe dysfunction of heart, lung and kidney
4. Poor status: Performance Status(ECOG) 3 or 4
5. VAS>20mm, BT>37.0(celsius) or WBC>normal range
6. Administration of steroid or pain killer
7. Administration of anti-cogulant drugs
8. Pregnancy
9. Inappropriateness with physician's judgement
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
tshimura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 18 | 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
| 2019 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
PECS was defined as either of the following findings after ESD:
1. VAS >= 30 mm or a raise of VAS >= 20 mm from baseline VAS
2. BT >= 37.5 celsius
3. WBC >= 10,000/ul
type I PECS: PECS without extra-luminal air
type II PECS: PECS with peri-luminal air
CT scan for all enrolled cases after ESD
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043371
