UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019157 |
|---|---|
| Receipt number | R000022149 |
| Scientific Title | Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor |
| Date of disclosure of the study information | 2015/09/29 |
| Last modified on | 2017/09/30 15:24:26 |
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Basic information
Public title
Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor
Acronym
Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor (D-CSP)
Scientific Title
Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor
Scientific Title:Acronym
Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor (D-CSP)
Region
| Japan |
Condition
Condition
Superficial Non-Ampullary Duodenal Epithelial Tumor (SNADET) <= 10mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of cold snare polypectomy (CSP)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Delayed perforation and bleeding
Key secondary outcomes
The rate of spurting bleeding just after CSP, en-block resection, R0 resection, residual tumor 3 months after CSP, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cold Snare Polypectomy (CSP)
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) superficial non-ampullary duodenal epithelial tumor <= 10mm
2) bulbs~3rd part of deudenum
3) one lesion
4) elevated lesion expected to remove en-block using snare
5) 20 years old and more
6) can be followed for 3 months
7) Written informed consent
Key exclusion criteria
1) Impossible to suspend anticoagulant or antiplatelet medications (except low-dose aspirin)
2) Infectious disease with systemic therapy indicated
3) Women during pregnancy or breast-feeding
4) Psychosis
5) Systemic steroids medication
6) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks
7) Severe respiratory disease requiring continuous oxygen therapy
8) Uncontrollable hypertension
9) Uncontrollable diabetes millutus
10) others
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ono |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
Shimonagakubo1007, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
h.ono@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Takizawa |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
Shimonagakubo1007, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
k.takizawa@scchr.jp
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer 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
Address
Tel
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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 29 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022149
