UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025913 |
|---|---|
| Receipt number | R000029794 |
| Scientific Title | The efficacy and safety of Cold Forceps Polypectomy for the non-ampullary dudenoal adenoma of less than 6mm. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2022/08/05 12:20:40 |
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Basic information
Public title
The efficacy and safety of Cold Forceps Polypectomy for the non-ampullary dudenoal adenoma of less than 6mm.
Acronym
The feasibility trial of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Scientific Title
The efficacy and safety of Cold Forceps Polypectomy for the non-ampullary dudenoal adenoma of less than 6mm.
Scientific Title:Acronym
The feasibility trial of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Region
| Japan |
Condition
Condition
non-ampullary duodenal adenoma of less than 6mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exame the feasibility of Cold Forceps Polypectomy for the non-ampullary duodenal adenoma of less than 6mm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
disappearance rate of adenoma by the Cold Forceps Polypectomy
Key secondary outcomes
1.Adverse event
2Total number of biopsy tissue
3.Total number of procedure
4.Procedure time
5.histlogical assessment
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
repeat the cold forceps biopsy to the lesion
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. endoscopically and histologicaly diagnosed as non-amupullary duodenal adenoma of less than 6mm.
2. without non-ampullary duodenal adenoma over 11mm
3. written informed consent was performed
Key exclusion criteria
1. can not performe biopsy because of the anti-coaglant drugs.
2. bad general status
3. pregnant or lactating
4. The cases who may not alive over one year.
5. physician judge to be inappropriate
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kanzaki |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
TEL
086-235-7219
Homepage URL
kanzaki@qc4.so-net.ne.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Department of Gastroenterology and Hepatology
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama
Tel
0862357219
mae6605@adm.okayama-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
岡山大学病院（岡山県）、津山中央病院（岡山県）、広島市立市民病院（広島県）、倉敷中央病院（岡山県）、姫路赤十字病院（兵庫県）、福山医療センター（広島県）、岡山市民病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35859656/
Number of participants that the trial has enrolled
39
Results
Primary outcome:
Tumor disappearance after one-year: 38/39 cases (97.4%)
Median tumor diameter: 5 (3-6) mm
Morphology: superficial elevated / superficial depressed / protruded = 19/13/7
Location: bulb / 2nd (pre-Vater) / 2nd (post-Vater) = 1/18/20
Results date posted
| 2020 | Year | 02 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to delay in paper submission
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 10 | Day |
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
| 2017 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Published on Endoscopy international Open
https://pubmed.ncbi.nlm.nih.gov/35859656/
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029794
