UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016829 |
|---|---|
| Receipt number | R000019531 |
| Scientific Title | Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2017/07/02 11:01:11 |
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Basic information
Public title
Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion
Acronym
Cold polypectomy for nonampullary duodenal adenoma
Scientific Title
Efficacy and safety of cold polypectomy for nonampullary duodenal adenomatous lesion
Scientific Title:Acronym
Cold polypectomy for nonampullary duodenal adenoma
Region
| Japan |
Condition
Condition
Nonampullary duodenal adenomatous lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy and safety of endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of pathological local recurrence at 3 months after endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion by biopsy from the scar after polypectomy
Key secondary outcomes
The rate of morphological local recurrence at 3 months after endoscopic cold polypectomy for nonampullary duodenal adenomatous lesion by biopsy from the scar after polypectomy and relationship between these and patients background or lesion information
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endoscopic cold polypectomy for nonampullary duodenal adenomatous lesions
Key exclusion criteria
Patients evaluated incompetent by doctors in attendance
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28493238
Number of participants that the trial has enrolled
Results
Overall, 39 lesions in 30 patients were removed via cold polypectomy (CFP, 9 lesions in 8 patients; CSP, 30 lesions in 22 patients). Seven of 9 (77.8%) and 29 of 30 (96.7%) lesions were removed en bloc via CFP and CSP, respectively. Pathologically, 34 of the 39 lesions (87.2%) were confirmed as adenomas, and their mean size was 3.9+-1.2mm (range 2-6mm). Of the 34 adenomas, 20 (58.8%) were R0 resection lesions, of which 3 of 9 (33.3%) and 17 of 25 (68.0%) had undergone CFP and CSP, respectively. No delayed bleeding or intraprocedural/delayed perforation was observed. All 30 patients with the 34 pathologically confirmed adenomas underwent upper gastrointestinal endoscopy 3 months after cold polypectomy, and no morphological or pathological recurrence was identified.
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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who had undergone cold polypectomy for nonampullary duodenal adenomatous lesion underwent periodic endoscopy and biopsied scar after cold polypectomy at 3 months after ESD.
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019531
